FDA Adverse Event
Injury
Summary report: N
SCREW LOCKING
MDR report key: 2926036
·
Received January 23, 2013
Report
- Report Number
- 2520274-2013-00540
- Event Type
- Injury
- Date Received
- January 23, 2013
- Date of Event
- August 19, 2012
- Report Date
- December 28, 2012
- Manufacturer
- SYNTHES (USA)
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE USED FOR TREATMENT AND 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
A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE, A DISCONNECTION OF THE EXTRACTION ARM COULD NOT BE ACHIEVED. THE DISTRACTOR WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS IS 4 OF 4 REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32466 | SCREW LOCKING | HWC | SYNTHES (USA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | DISTRACT-BODY, MESH FOOT, LOCKING SCREW |