FDA Adverse Event
Malfunction
Summary report: N
CONNECTING BOLT OMEGA
MDR report key: 1915337
·
Received November 17, 2010
Report
- Report Number
- 8031020-2010-00159
- Event Type
- Malfunction
- Date Received
- November 17, 2010
- Date of Event
- October 14, 2010
- Report Date
- October 28, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
CUSTOMER REPORTED VIA SALES REP THAT THE STRAND OF THE THREAD BROKE DURING THE SURGERY. THERE WAS NO DELAY. THE SURGERY WAS FINISHED WITH ANOTHER ITEM AVAILABLE WITH NO MORE ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONNECTING BOLT OMEGA | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | H06404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |