FDA Adverse Event
Malfunction
Summary report: N
CRW MAYFIELD ADAPTOR
MDR report key: 5361700
·
Received January 12, 2016
Report
- Report Number
- 3004608878-2016-00008
- Event Type
- Malfunction
- Date Received
- January 12, 2016
- Date of Event
- November 18, 2015
- Report Date
- December 10, 2015
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION OH/USA
- Product Code
- HAW
- PMA / PMN Number
- K944463
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2016 FROM THE CUSTOMER: ON (B)(6) 2015, A (B)(6) YEAR OLD MALE UNDERWENT A DEEP BRAIN STIMULATOR LEAD PLACEMENT. THE PROBLEM WITH THE TRUNION RING OCCURRED DURING POSITIONING OF THE PATIENT. THE SURGERY WAS DELAYED ABOUT 45 MINUTES WHILE A NEW MAYFIELD WAS FOUND AND APPLIED. THERE WAS NO PATIENT ADVERSE CONSEQUENCE AS A RESULT OF THE SURGERY DELAY. EVALUATION OF COMPLAINT RELATED DEVICE IS IN PROGRESS.
Description of Event or Problem · 1
THE INITIAL MDR WAS SENT UNDER FACILITY ESTABLISHMENT INTEGRA (B)(4)., MANUFACTURER REPORT NUMBER 1222895-2015-00051. THE CORRECT FACILITY ESTABLISHMENT IS INTEGRA LIFESCIENCES CORPORATION OH/USA. HENCE, THIS FOLLOW UP MDR IS BEING SENT AS A CORRECTION ON THE FACILITY ESTABLISHMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19925 | CRW MAYFIELD ADAPTOR | N/A | HAW | INTEGRA LIFESCIENCES CORPORATION OH/USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |