FDA Adverse Event
Malfunction
Summary report: N
METRX
MDR report key: 2991362
·
Received March 6, 2013
Report
- Report Number
- 1030489-2013-00695
- Event Type
- Malfunction
- Date Received
- March 6, 2013
- Date of Event
- February 4, 2013
- Report Date
- April 5, 2013
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION: THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INFERIOR STATIC JAW IS BENT AND BROKEN AT THE CENTERLINE OF THE PIVOT PIN HOLE. THE LOCATION, DIRECTION AND AMOUNT OF FORCE REQUIRED IN ORDER TO BEND AND INDUCE FRACTURE OF THE JAW, IS CONSISTENT BEND STRESS OVERLOAD.
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 TIP OF THE PITUITARY BROKE OFF DURING AN UNKNOWN SPINAL PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95615 | METRX | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | MEDTRONIC SOFAMOR DANEK USA, INC | NA | GZ10M029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |