MAUDE Adverse Event Report: ZIMMER SPINE INSTINCT JAVA POLYAXIAL PEDICLE SCREW DG 50

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 05/02/2016

Event Type  Injury  

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.Two lots were returned that were not reported, therefore initial reports 3003853072-2016-00103 and 3003853072-2016-00104 were submitted.Reference supplemental reports 3003853072-2016-00060-1 through 3003853072-2016-00064-1.

Event Description

Since (b)(6) 2015, the patient had begun experiencing increasing low back pain.On (b)(6) 2016, it is noted in an office note that there is evidence of a broken screw.No specific occurrences (e.G.Trauma, non-compliance) are related to this occurring.The patient's bone quality and current status/condition was not indicated.It is reported fusion did not occur.No x-rays or surgical report are available at this time.Indication of the initial surgery degenerative disc at lumbar 4-5, 5-sacral 1 with spondylolisthesis.Description of the construct implanted during the initial surgery.Lumbar 4-5-sacral 1 pedicle screws with cross connector.

Manufacturer Narrative

The investigation was completed with the returned construct parts and the information available.A review of the manufacturing records did not find any issues which would have contributed to this event.The root cause of this event cannot be conclusively determined, however, as the hardness and micrographic structure were tested and shown to be perfectly consistent with a ta6v-type titanium alloy, it is likely that the device broke following a phenomenon of progressive cracking attributable to repeated cyclic flexion.

• Brand Name: INSTINCT JAVA POLYAXIAL PEDICLE SCREW DG 50
• Type of Device: SCREW
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux 33080 ; FR 33080
• Manufacturer (Section G): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux 33080 ; FR 33080
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047419468
• MDR Report Key: 5786069
• MDR Text Key: 49293878
• Report Number: 3003853072-2016-00103
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• 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: 046W0AN25550
• Device Lot Number: H22213H
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 107