MAUDE Adverse Event Report: ZIMMER SPINE POLYAXIAL PEDICLE SCREW DG 40; INSTINCT JAVA SYSTEM

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 10/19/2016

Event Type  Injury  

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.This is report three of six for this event.Reference report numbers 3003853072-2016-00151 thru 3003853072-2016-00156.

Event Description

It was reported that approximately 15 months after installation, the patient presented to the surgeon with pain.X-rays were taken and the surgeon saw signs that the tulip of the pedicle screw at left l-3 detached from the screw shank.It appeared that the pedicle screw at right l-3 was also broken, as well as the rod between the l-3 and l-4 levels.A revision surgery was performed to remove and replace the implants.There were a total of two rods and four pedicle screws removed; it is not yet clear which rod and pedicle screws are broken.

Manufacturer Narrative

The device was not returned, so an evaluation could not be performed and no conclusions could be drawn.A review of the manufacturing records did not identify any issues which may have contributed to this event.The labeling was reviewed and found to contain information regarding post-operative expectations.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

The returned screw was evaluated.The threaded shaft was found to have fractured; the complaint is confirmed.The evaluation confirmed that the micrographic structure of the material and the hardness are compliant with specifications and there were no particular metallurgical defects found.The root cause is likely attributed to fatigue breakage led by a combination of patient factors and surgical strategy applications.

Manufacturer Narrative

Additional information in patient identifier, age or date of birth, weight.

• Brand Name: POLYAXIAL PEDICLE SCREW DG 40
• 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, CO 80021 ; 3034437500
• MDR Report Key: 6173309
• MDR Text Key: 62334171
• Report Number: 3003853072-2016-00153
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup,Followup,Followup
• Report Date: 01/30/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 046W0AN26540
• Device Lot Number: H18766J
• Other Device ID Number: (01)00889024340275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2016
• Initial Date FDA Received: 12/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/28/2017; 01/03/2018
• Supplement Dates FDA Received: 02/23/2017; 06/19/2017; 10/02/2017; 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2013
• 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: 52 YR
• Patient Weight: 74