FDA Adverse Event
Other
Summary report: N
M 3-D PLATTE, 2X2+2 LOCH
MDR report key: 536823
·
Received July 28, 2004
Report
- Report Number
- 8010177-2004-00014
- Event Type
- Other
- Date Received
- July 28, 2004
- Date of Event
- June 23, 2004
- Report Date
- June 23, 2004
- Manufacturer
- STRYKER LEIBINGER FREIBURG GMBH & CO. KG
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FOR THE FRACTURE AT 1ST METACARPAL OSTEOSYNTHESIS WAS DONE IN 2004. ABOUT 1 MONTH AFTER SURGERY, IT WAS FOUND THAT THE PLATE WAS BROKEN, AND REVISION SURGERY WAS DONE IN 2004.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | M 3-D PLATTE, 2X2+2 LOCH | BONE PLATE | HRS | STRYKER LEIBINGER FREIBURG GMBH & CO. KG | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |