FDA Adverse Event
Injury
Summary report: N
SCREW
MDR report key: 2872278
·
Received December 13, 2012
Report
- Report Number
- 2520274-2012-03867
- Event Type
- Injury
- Date Received
- December 13, 2012
- Report Date
- November 14, 2012
- Manufacturer
- SYNTHES USA
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH A PLATE AND SCREW CONSTRUCT ON (B)(6) 2011. ON AN UNKNOWN DATE, PATIENT COMPLAINED OF PAIN FROM A HEALED FRACTURE. THE SURGEON DECIDED TO REMOVE HARDWARE TO ALLEVIATE THE PAIN. PATIENT RETURNED TO THE OR ON (B)(6) 2012 AND THE HARDWARE WAS REMOVED. THIS IS 5 OF 9 REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREW | HWC | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention | SCREW X 7, PLATE X 1 |