MAUDE Adverse Event Report: STRYKER SPINE-FRANCE MACC STANDARD MULTI AXIAL CONNECTOR 39-43 MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	48213038
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	01/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a previous surgery from t10-l5.Dr.(b)(6) that he was not fused at l2-3 where both rods broke.The crosslink also broke.Both rods and crosslink were replaced.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment results: the reported device fracture was confirmed via a visual inspection.No relevant manufacturing issues were identified during review of the manufacturing records.Conclusion: the likely root cause of this event is due to a non-union (patient didn't fuse).
Event or Problem Description
It was reported that the patient had a previous surgery from t10-l5.Dr.Said that he was not fused at l2-3 where both rods broke.The crosslink also broke.Both rods and crosslink were replaced.

• Brand Name: MACC STANDARD MULTI AXIAL CONNECTOR 39-43 MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5413789
• Report Number: 0009617544-2016-00049
• Device Sequence Number: 16328656
• Product Code: MNI
• UDI-Device Identifier: 07613154345076
• UDI-Public: 07613154345076
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K000965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Followup
• Report Date (Section B): 01/14/2016

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48213038
• Device Lot Number: 07E410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2016
• Supplement Report FDA Received Date: 05/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention