MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM LONG OFFSET CONNECTOR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48230133
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Upon final tightening of a set screw of the offset connector, the set screw fractured.The offset connector was replaced with another same new one.
Event or Problem Description
Upon final tightening of a set screw of the offset connector, the set screw fractured.The offset connector was replaced with another same new one.
Additional Manufacturer Narrative
Method: product history review, complaint history review, labelling review, risk assessment.Result: the customer reported event was confirmed via correspondence with the rep.All broken fragments were recovered.The device was not returned as it was disposed of at the hospital, so inspection could not be completed.Manufacturing records for the reported lot were reviewed and no relevant issues were identified.It was reported that it was unknown if cross thread occurred, but at the time of final tightening abnormal sound heard.Cross threading of the screw would cause a squeaking noise when the screw is tightened down as the threads deform from being misaligned and forced down.Conclusion: as the device was not available for evaluation, a definite root cause cannot be determined.It is also possible excessive force was applied, the set screw was previously damaged/deformed, insufficient visibility, and/or incorrect alignment of the connector on to the rod.

• Brand Name: XIA 3 TITANIUM LONG OFFSET CONNECTOR
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7812388
• Report Number: 3005525032-2018-00052
• Device Sequence Number: 1116967
• Product Code: MNH
• UDI-Device Identifier: 04546540602282
• UDI-Public: 04546540602282
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48230133
• Device Lot Number: AB58806
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR