MAUDE Adverse Event Report: ZIMMER SPINE PEDICLE SCREW; INSTINCT JAVA SYSTEM

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 12/01/2016

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.This is report one of two for this event.Reference report 3003853072-2016-00163.

Event Description

It was reported that two pedicle screws at l1 were broken in the threaded shaft region outside of the vertebral bodies approximately 14 months post-op.A revision surgery is planned for (b)(6) 2017.

Manufacturer Narrative

The device was not returned for evaluation.A photo of the x-ray was provided and shows the screw shaft fractured in the threaded region.The labeling was reviewed and found to contain post-operative warnings and instructions.

• Brand Name: PEDICLE SCREW
• Type of Device: INSTINCT JAVA SYSTEM
• 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 ; 310 interlocken pkwy ste. 120; broomfield 80021 ; 3034437500
• MDR Report Key: 6188645
• MDR Text Key: 62839705
• Report Number: 3003853072-2016-00161
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: PK111301
• 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: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN INSTINCT PEDICLE SCREW
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 27 YR