FDA Adverse Event
Malfunction
Summary report: N
DRILL BIT 2.5X180MM AO FITTING
MDR report key: 2182162
·
Received June 23, 2011
Report
- Report Number
- 8031020-2011-00143
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 8, 2011
- 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
DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT HAS BEEN REPORTED VIA SALES REP THAT DURING THE SURGERY (DATED ON (B)(6) 2011), WHEN THE SURGEON WAS TRYING TO PUT A MATTA PLATE, THE ITEM (B)(4) BROKE. IT HAS BEEN ALLEGED BY THE CUSTOMER THAT ALL THE PRODUCT WAS RECOVERED FROM THE PT'S BODY. NO MORE ADVERSE CONSEQUENCES WERE REPORTED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRILL BIT 2.5X180MM AO FITTING | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | W26280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |