FDA Adverse Event
Injury
Summary report: N
UNKNOWN_OSTEOSYNTHESIS_PRODUCT
MDR report key: 3230726
·
Received July 17, 2013
Report
- Report Number
- 0008031020-2013-00234
- Event Type
- Injury
- Date Received
- July 17, 2013
- Date of Event
- June 25, 2013
- Report Date
- June 25, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-SELZACH
- Product Code
- HTY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A (B)(6) THAT HAD AN ANKLE FUSION SIX MONTHS AGO WITH 6.5 ASNUS SCREWS AND DEVELOPED A NON UNION. SURGEON TOOK OUT 3 6.5 ASNUS SCREWS AND PUT ON EXTERNAL FIXATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331581 | UNKNOWN_OSTEOSYNTHESIS_PRODUCT | IMPLANT | HTY | STRYKER OSTEOSYNTHESIS-SELZACH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Required Intervention |