FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT - SCREW
MDR report key: 2001685
·
Received February 22, 2011
Report
- Report Number
- 9610622-2011-00076
- Event Type
- Injury
- Date Received
- February 22, 2011
- Date of Event
- February 2, 2011
- Report Date
- February 4, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HWC
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SAME PT AS MDR 96140622-2011-00075.
Description of Event or Problem · 1
CUSTOMER REPORTED VIA SALES REP THAT THE PRODUCT WAS IMPLANTED INTO THE PT SUCCESSFULLY. PT WAS DISCHARGED. THE FIRST IMPLANT WAS DONE IN (B)(6) 2010. THE CUSTOMER FURTHER ADDED THAT ABOUT 6 MONTHS AFTER THE FIRST IMPLANT THE DISTAL LOCKING SCREW BROKE. THE NAIL BROKE WHICH LEAD TO THE PT HAVING REVISED SURGERY ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT - SCREW | IMPLANT | HWC | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |