Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4712811 | 6003135 | I | 4712811-3 | 20040126 | 20050712 | EXP | CTU 253062 | STRYKER BIOTECH | 34 | YR | M | N | 20041215 | MD | UNITED STATES |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 4712811 | 1006199126 | PS | BONE TISSUE HUMAN | 1 | ONE VIAL -IMPLANTED | FD0312002 | |||||
| 4712811 | 1006213108 | SS | AUTOGRAFT -OSTEOSET PELLETS | 2 | 10 CC- IMPLANTED | 03343025 | |||||
| 4712811 | 1006213109 | SS | BONE TISSUE HUMAN | 1 | 10CC |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 4712811 | 1006199126 | ANKLE FRACTURE |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 4712811 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 4712811 | IMPAIRED HEALING |
| 4712811 | POSTOPERATIVE INFECTION |
| 4712811 | SKIN NECROSIS |
| 4712811 | SURGICAL PROCEDURE REPEATED |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 4712811 | 1006199126 | 20040126 |