FDA Adverse Event
Malfunction
Summary report: N
BONE ANCHOR 020-1101 WITH ALIGNMENT ROD
MDR report key: 4605872
·
Received March 16, 2015
Report
- Report Number
- 1723170-2015-00320
- Event Type
- Malfunction
- Date Received
- March 16, 2015
- Date of Event
- February 16, 2015
- Report Date
- February 16, 2015
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAO
- PMA / PMN Number
- K081656
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS. PART NOT RETURNED TO MANUFACTURER.
Additional Manufacturer Narrative · 1
PATIENT INFORMATION NOW PROVIDED. PATIENT WEIGHT WAS NOT AVAILABLE.
Description of Event or Problem · 1
A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL PROCEDURE, APPROXIMATELY 5 MILLIMETERS OF THE BONE ANCHOR BROKE OFF WITHIN THE PATIENT'S HEAD. THE SURGEON REPORTED THAT THIS OCCURRED AS THE PATIENT WOKE UP FROM ANESTHESIA AND MOVED HIS, OR HER, HEAD. THE SURGEON OPTED TO LEAVE THE BONE ANCHOR INSTEAD OF EXTRACTING IT. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE THERMAL THERAPY SYSTEM . THERE WAS NO IMPACT ON PATIENT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177609 | BONE ANCHOR 020-1101 WITH ALIGNMENT ROD | INSTRUMENT, SURGICAL, NON-POWERED | HAO | MEDTRONIC NAVIGATION, INC. | BA-320-185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |