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 Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; screw 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.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: 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.Conclusion: the plausible root cause of the event is user issue.
Event or Problem Description
It was reported that; screw 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: 6458099
• Report Number: 0009617544-2017-00121
• Device Sequence Number: 16291336
• 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?: Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR