FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 1203383
·
Received October 10, 2008
Report
- Report Number
- 1030489-2008-00563
- Event Type
- Malfunction
- Date Received
- October 10, 2008
- Date of Event
- September 15, 2008
- Report Date
- September 15, 2008
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- HXX
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. VISUAL EXAMINATION CONFIRMED TWO CRACKS ON EACH SIDE OF THE HEX TIP EXTENDING APPROXIMATELY 2MM TOWARDS THE DISTAL END OF THE SPRING TAB.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TORQUE LIMITING DRIVER WAS NOT TIGHTENING THE IMPLANT PROPERLY AND APPEARED TO BE FRACTURED AT THE TIP. NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | DRIVER | HXX | MEDTRONIC SOFAMOR DANEK | NA | BM06H011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |