FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 2152056
·
Received July 7, 2011
Report
- Report Number
- 1030489-2011-00857
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- June 2, 2011
- Report Date
- June 6, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- HXX
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELECTIVE REVISION SURGERY TO HAVE THE HARDWARE REMOVED. DURING REMOVAL OF A BONE SCREW THE TIP OF THE DRIVER BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | SCREWDRIVER | HXX | MEDTRONIC SOFAMOR DANEK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | BONE SCREW |