MAUDE Adverse Event Report: ZIMMER SPINE TL PEDICLE SCREW D7 LG 35; JAVA TOP LOADING

Catalog Number SN2023-0-23507

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 05/12/2018

Event Type  Injury  

Manufacturer Narrative

This device is similar to those cleared by k111301.There was not a death or serious injury associated with this event.This malfunction has not been previously reported on this or a similar device and is not likely to lead to a death or serious injury if it were to recur.Therefore, this event is not reportable.Reference report 3003853072-2018-00046.

Event Description

It was reported that a revision surgery was performed to remove and replace two screws which were broken post-operatively.There were no reported patient impacts associated with the revision surgery.This is report two of two for this event.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Manufacturer Narrative

The returned screw was evaluated.The screw shaft was found to have fractured.The cause cannot be determined with the available information.A review of the manufacturing records did not find any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper use and also listed implant fracture as a possible side effect of using the device.

Event Description

It was reported that a revision surgery was performed to remove and replace two screws which were broken post-operatively.There were no reported patient impacts associated with the revision surgery.This is report two of two for this event.

• Brand Name: TL PEDICLE SCREW D7 LG 35
• Type of Device: JAVA TOP LOADING
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• MDR Report Key: 7609395
• MDR Text Key: 111321580
• Report Number: 3003853072-2018-00047
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SN2023-0-23507
• Device Lot Number: H20173K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention