FDA Adverse Event Malfunction Summary report: N

TI MATRIX TOP LOADING POLYAXIAL HEAD

MDR report key: 3843685 · Received June 2, 2014

Report

Report Number: 2520274-2014-11650
Event Type: Malfunction
Date Received: June 2, 2014
Date of Event: May 7, 2014
Report Date: May 7, 2014
Manufacturer: SYNTHES USA
Product Code: NKB
PMA / PMN Number: PK100952
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

EVENT DATE: UNKNOWN. ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, KWP. DEVICE HAS NOT BEEN EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DOCTOR NOTICED THAT THE POLYAXIAL HEAD OF THE MATRIX-POP-ON SCREW HAD COME OFF POST-OPERATIVELY. THE DEVICES WERE USED AT AN OPERATION FOR LUMBAR DISC HERNIATION ON (B)(6) 2014. AFTER THE OPERATION, DURING OUTPATIENT VISIT, THE DOCTOR NOTICED THAT THE POLYAXIAL HEAD OF THE MATRIX-POP-ON SCREW HAD COME OFF, WHILE X-RAYING THE PATIENT. IT MAY HAVE BEEN THAT THE POLYAXIAL HEAD WAS NOT FIXED FIRMLY ENOUGH, DURING THE OPERATION. SINCE FACET STILL REMAINS, A RE-OPERATION WILL NOT BE DONE AND THE DOCTOR WILL FOLLOW-UP ON THE PATIENT¿S CONDITION. THIS IS REPORT 1 OF 1 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
321852	TI MATRIX TOP LOADING POLYAXIAL HEAD	ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD	NKB	SYNTHES USA

Patients

Seq	Age	Sex	Outcome	Treatment
1