FDA Adverse Event
Malfunction
Summary report: N
QUICK-RELEASE SELF-HOLDING SCREWDRIVER
MDR report key: 2231821
·
Received September 1, 2011
Report
- Report Number
- 1030489-2011-01117
- Event Type
- Malfunction
- Date Received
- September 1, 2011
- Date of Event
- August 9, 2011
- Report Date
- August 9, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A C3-C7 LAMINECTOMY AND FUSION FOR MYELOPATHY. DURING THE PROCEDURE, IT WAS NOTICED THAT THE SCREWDRIVER COULD NOT BE DISENGAGED FROM THE SCREWS. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICK-RELEASE SELF-HOLDING SCREWDRIVER | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00059 YR |