MAUDE Adverse Event Report: ZIMMER SPINE POLYAXIAL PEDICLE SCREW 6,5 LG 40; INSTINCT JAVA SYSTEM

Catalog Number 046W0AN26540

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 3003853072-2020-00008 to 3003853072-2020-00020 and 3012447612-2020-00158.

Event Description

It was reported that an instinct java spondylolisthesis correction construct was found to have failed 1.5 months postoperatively after the patient presented for low back pain.There were no additional patient impacts reported and no revision is scheduled at this time.This is report seven of fourteen for this event.

Manufacturer Narrative

Additional information in b4, g4, g7, h2, h6: methods, results, and conclusion codes.The product was not returned and no photos were provided, so an evaluation is unable to be performed.The lot number was not provided and a device history review cannot be conducted.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.Provided x-rays demonstrate the recurrence of the spondylolisthesis.The complaint is confirmed.A definitive root cause cannot be determined.

Event Description

It was reported that an instinct java spondylolisthesis correction construct was found to have failed 1.5 months postoperatively after the patient presented for low back pain.There were no additional patient impacts reported and no revision is scheduled at this time.This is report seven of fourteen for this event.

• Brand Name: POLYAXIAL PEDICLE SCREW 6,5 LG 40
• Type of Device: INSTINCT JAVA SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• MDR Report Key: 9782662
• MDR Text Key: 184745567
• Report Number: 3003853072-2020-00014
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 046W0AN26540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR