FDA Adverse Event
Malfunction
Summary report: N
METRX
MDR report key: 2864356
·
Received December 10, 2012
Report
- Report Number
- 1030489-2012-02764
- Event Type
- Malfunction
- Date Received
- December 10, 2012
- Date of Event
- November 9, 2012
- Report Date
- November 13, 2012
- Manufacturer
- MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CORRECTED INFORMATION: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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 THE PATIENT UNDERWENT A LUMBAR LAMINECTOMY. IT WAS REPORTED THAT THE TIP OF THE UPBITING MICRO-PITUITARY FELL OFF DURING SURGERY. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | METRX | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING | NA | GZ07D112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |