FDA Adverse Event Other Summary report: N

DTL CANN. PEDICLE+SET SCREW 6.4X50

MDR report key: 3772292 · Received March 23, 2014

Report

Report Number: 9613350-2014-03391
Event Type: Other
Date Received: March 23, 2014
Date of Event: February 28, 2014
Report Date: February 28, 2014
Manufacturer: ZIMMER GMBH
Product Code: NQP
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE MANUFACTURER DID NOT RECEIVE THE DEVICES FOR REVIEW AS THE PT HAS NOT BEEN REVISED. X-RAYS AND OTHER SOURCE DOCUMENTS WERE PROVIDED (PATIENT HISTORY, SCREW, SPACER AND CORD CATALOG NUMBER). AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ANOTHER REPORT WILL BE SENT FOR THE OTHER SCREW (L3) THAT ON THE X-RAY LOOKS LIKE ONE OF THE TOP SCREWS MAY HAVE BEEN PLACED WITH THE TIP BEYOND THE CORTICAL WALL AS WELL. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PT RECEIVED A DTL CANN. PEDICLE+SET SCREW 6.4X50 ON (B)(6) 2013. (B)(6). IT IS STATED THAT "CORE LAB ANALYSIS OF 6 MONTH POST-OP FILMS SHOWS 8 MM ANTERIOR CORTICAL VIOLATION OF L4 SCREW SEEN ON LATERAL VIEW. NO ASSOCIATED ADVERSE EVENT OR SERIOUS ADVERSE EVENT HAS BEEN REPORTED BY THE SITE FOR THIS". IT WAS ALSO MENTIONED THAT THE TOP SCREW (L3) MAY HAVE BEEN PLACED WITH THE TIP BEYOND THE CORTICAL SCREW AS WELL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
171267	DTL CANN. PEDICLE+SET SCREW 6.4X50	DYNESYS TOP-LOADING SPINAL SYSTEM	NQP	ZIMMER GMBH		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Other