FDA Adverse Event
Malfunction
Summary report: N
OPEN SPINE CLAMP, TITANIUM
MDR report key: 3122908
·
Received May 21, 2013
Report
- Report Number
- 1723170-2013-00364
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Date of Event
- May 22, 2013
- Report Date
- May 22, 2013
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
BOTH SCREW DEVICES ON THE CLAMP FUNCTION PROPERLY. THEY ARE NOT STRIPPED. THE CLAMP BODY IS BROKEN, IT HAS BEEN FRACTURED. A NEW CLAMP WAS SENT TO THE SITE FOR ISSUE RESOLUTION.
Additional Manufacturer Narrative · 1
NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN.DEVICE LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE AT TIME OF THIS REPORT.DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SN, THEREFORE, UNAVAILABLE AT THIS TIME.RMA ISSUED. REPLACEMENT SPINE CLAMP SHIPPED TO SITE (B)(4) 2013. SUSPECT DEVICE HAS NOT YET BEEN RETURNED TO MANUFACTURER FOR EVALUATION.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED A SITE LONG SPINE CLAMP THAT WAS STRIPPED. THERE WAS NO PATIENT PRESENT WHEN THIS WAS IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224312 | OPEN SPINE CLAMP, TITANIUM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC. | 120726 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |