FDA Adverse Event
Malfunction
Summary report: N
CONE BODY TRIAL TRAY #2 RESTORATION MODULAR
MDR report key: 1925114
·
Received November 23, 2010
Report
- Report Number
- 2249697-2010-01616
- Event Type
- Malfunction
- Date Received
- November 23, 2010
- Date of Event
- October 27, 2010
- Report Date
- November 2, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE CUSTOMER, REPORTED VIA THE COMPETENT AUTHORITY, (B)(6) THAT THE INSTRUMENTS WITHIN THE LOAN KITS WERE FOUND TO HAVE SMALL FRAGMENTS OF BONE IN THEM AND SMALL AMOUNTS OF HARD BLOOD DEPOSITS. IT IS FURTHER REPORTED THAT THE TRAYS ARE COVERED IN TACKY TAPE RESIDUE AND NOT CLEANED OFF HOLDING FOREIGN BODY DEPOSITS OF PAPER DUST AND FIBRES. IT IS FURTHER REPORTED THAT THERE ARE VARIOUS ITEMS ASSOCIATED WITH THIS EVENT. IT IS FURTHER REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONE BODY TRIAL TRAY #2 RESTORATION MODULAR | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |