MAUDE Adverse Event Report: ZIMMER SPINE TL PEDICLE SCREW, DIA 6.5 X 45MM; JAVA TOP LOADING

Catalog Number SN2023-0-24565

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 04/11/2017

Event Type  Injury  

Manufacturer Narrative

This device is not cleared for use in or marketed within the us.It is a similar product to those cleared by k111301 under product code nkb.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3003853072-2017-00049 thru 3003853072-2017-00051.

Event Description

It was reported that three pedicle screws fractured post-operatively.The screws were installed for approximately three years prior to the breakage.A revision surgery was performed to address the broken screws.There were no other reports of patient injury associated with this event.This is report one of three for this event.

Manufacturer Narrative

The device was not returned for evaluation, however photographs were provided and used for the evaluation.The threaded shaft had fractured; the complaint is confirmed.The fractured screws were found four years after being implanted and bony fusion was achieved at the site.It cannot be concluded that the screws broke before the fusion occurred.A review of the device labeling shows that this is a known risk of the procedure since repeated stresses on the devices over time can lead to device fracture.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: TL PEDICLE SCREW, DIA 6.5 X 45MM
• Type of Device: JAVA TOP LOADING
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• Manufacturer (Section G): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 6570786
• MDR Text Key: 75305437
• Report Number: 3003853072-2017-00049
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PNA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SN2023-0-24565
• Device Lot Number: H17610B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: 09/04/2017
• Supplement Dates FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 32 YR