INFIX

MDR report key: 4210810 · Received August 1, 2014

Report

Report Number: 2184052-2014-00125
Event Type: Malfunction
Date Received: August 1, 2014
Date of Event: July 7, 2014
Report Date: July 7, 2014
Manufacturer: ZIMMER SPINE, INC.
Product Code: MQP
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SD, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL RELEVANT INFO WILL BE PROVIDED WHEN THE DEVICE EVAL IS COMPLETED.

Description of Event or Problem · 1

SAME CASE AS MDR IDS: 2184052-2014-00121, 00124, 00123, 00126, 00120, 00122. IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SURGERY, IMPLANT LOCKING DIFFICULTY OCCURRED. PT WAS UNDERGOING A THREE LEVEL ALIF TREATMENT PROCEDURE FOR DEGENERATIVE DISC DISEASE. AN INFIX IMPLANT, CONSISTING OF TWO SMALL 10MM STRUTS, ONE 0 DEGREE ENDPLATE AND ONE 9 DEGREE ENDPLATE, WAS IMPLANTED AND LOCKED IN THE L5-S1 DISC SPACE WHILE USING A NON-ZIMMER RETRACTOR SYSTEM FOR ACCESS. AFTER IMPLANTING THE DEVICE, NEURO-MONITORING INDICATED POSSIBLE BILATERAL FOOT DROP. THE IMPLANT WAS THEN REMOVED. HOWEVER THE MONITORING CONTINUED TO SHOW SIGNS OF FOOT DROP. THEREFORE DISTRACTION WAS RELEASED BY REMOVING THE RETRACTOR SYSTEM AND MONITORING SHOWED THE ISSUE WAS RESOLVED. A SECOND INFIX IMPLANT CONSISTING OF TWO 8MM STRUTS WITH TWO 9 DEGREE ENDPLATES WAS THEN INSERTED INTO THE L5-S1 DISC SPACE. AN ATTEMPT WAS MADE TO LOCK THE IMPLANT. VERIFICATION X-RAYS WERE TAKEN AND SHOWED THAT THE SUPERIOR PLATE WAS JETTING OUT ABOUT 2MM. ADDITIONAL ATTEMPTS TO LOCK WERE UNSUCCESSFUL. THE IMPLANT WAS REMOVED AND THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE. ESTIMATED TOTAL SURGICAL DELAY WAS 2 HOURS. THERE HAVE BEEN NO REPORTED POST-OPERATIVE COMPLICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
452146	INFIX	STRUT, MEDIUM, 08MM	MQP	ZIMMER SPINE, INC.	1804-308

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR