FDA Adverse Event
Malfunction
Summary report: N
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
MDR report key: 2240700
·
Received September 9, 2011
Report
- Report Number
- 1030489-2011-01145
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- August 11, 2011
- Report Date
- August 12, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE HISTORY RECORDS FOR THIS LOT WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NONCONFORMANCE TO SPECIFICATION.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE FLEX ARM WILL NOT TIGHTEN PROPERLY. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING | NA | MY09A001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |