FDA Adverse Event
Malfunction
Summary report: N
IM REAMER, AO FITTING 10,5X480 MM
MDR report key: 2088814
·
Received May 4, 2011
Report
- Report Number
- 9610622-2011-00198
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- April 18, 2011
- Report Date
- April 18, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADD'L LOT#: K227142.
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED THAT THE OUTER METALLIC LAYER OF ALL THREE REAMERS GOT BENT AND BULGED TO OUT SIDE. A PT WAS INVOLVED AND THE SURGEON CHANGED THE REAMER AND CONTINUED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IM REAMER, AO FITTING 10,5X480 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | K125967 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |