FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 1060760
·
Received June 12, 2008
Report
- Report Number
- 1030489-2008-00275
- Event Type
- Malfunction
- Date Received
- June 12, 2008
- Date of Event
- June 27, 2007
- Report Date
- May 15, 2008
- Manufacturer
- WARSAW ORTHOPEDIC INC
- Product Code
- LXH
- PMA / PMN Number
- K973854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVAL. VISUAL MACROSCOPIC EXAM SHOWS THAT THE PARTS IN QUESTION ARE FROM 2 DIFFERENT SYSTEMS, BUT FIT TOGETHER. BOTH SEEM TO BE IN WORKING ORDER. CARELESS USE OF THE DRILL STOP COULD RESULT IN IT SLIPPING ALONG THE SHAFT AT THE DRILL. IN ADDITION, DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.
Description of Event or Problem · 1
IT WS REPORTED THAT THE DRILL STOP WOULD NOT HOLD, AND THE DRILL BIT PASSED THROUGH THE VERTEBRA WHILE DRILLING. NO OTHER PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | DRILL STOP | LXH | WARSAW ORTHOPEDIC INC | NA | 67118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |