FDA Adverse Event
Malfunction
Summary report: N
METRX FLEX ARM
MDR report key: 3230125
·
Received July 16, 2013
Report
- Report Number
- 1030489-2013-03048
- Event Type
- Malfunction
- Date Received
- July 16, 2013
- Date of Event
- June 19, 2013
- Report Date
- November 14, 2013
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Additional Manufacturer Narrative · 1
ANALYSIS OF THE RETURNED DEVICE SHOWS THAT FUNCTIONALLY EVALUATED FLEX ARM RIGIDITY BY ATTEMPTING TO MANUALLY TIGHTEN THE INSTRUMENT. AFTER MANUAL TIGHTENING, THE INSTRUMENT WAS INSUFFICIENTLY RIGID. THE MECHANISM OF FAILURE IS CONSISTENT WITH ANTICIPATED WEAR OF THE INSTRUMENT CABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. DURING THE PROCEDURE, "THE FLEX ARM WOULD NOT STAY FIXED AND THE SURGEON THINKS SOME PARTS INSIDE MAY BE BROKEN." NO FURTHER DETAILS ARE KNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328730 | METRX FLEX ARM | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | MEDTRONIC SOFAMOR DANEK USA, INC | MY11G001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR |