MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 4.5 X 40 TITANIUM PREBENT AND PRECUT ROD W/OUT HEX; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	481321040
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	03/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; screws in an l5/s1 fusion pulled out of the l5 screws bilaterally.Update 3/8/2017: correction: the rods pulled out of the l5 screws.The blockers were still engaged in the l5 screws and difficult to remove.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.The returned device was confirmed to be fractured.Upon device history review, all manufactured units met specification.No relevant manufacturing issues found.The rod was confirmed via visual inspection and xray images.The plausible root cause of the event is user issue.
Event or Problem Description
It was reported that; screws in an l5/s1 fusion pulled out of the l5 screws bilaterally.Update (b)(6) 2017: correction: the rods pulled out of the l5 screws.The blockers were still engaged in the l5 screws and difficult to remove.

• Brand Name: XIA 4.5 X 40 TITANIUM PREBENT AND PRECUT ROD W/OUT HEX
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6458104
• Report Number: 0009617544-2017-00122
• Device Sequence Number: 580536
• Product Code: NKB
• UDI-Device Identifier: 07613327001365
• UDI-Public: (01)07613327001365
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K092605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

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: 481321040
• Device Lot Number: RBA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR