MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 BLOCKER; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48130000
Medical Device Problem Codes	Mechanical Problem (1384); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); No Code Available (3191)
Date of Event	07/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; explanted rods and set screws.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: blocker main body migration post-op was confirmed via visual inspection.No relevant manufacturing issues were identified as all units met stryker specifications.Blockers were able to hold down a test rod in a test screw.Conclusion: it appears that the likely root cause of this event is due to the instability in the construct due to the inconsistency of the blocker tightening.
Event or Problem Description
It was reported that; explanted rods and set screws.

• Brand Name: XIA TITANIUM 4.5 BLOCKER
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6811845
• Report Number: 0009617544-2017-00330
• Device Sequence Number: 1760468
• Product Code: KWP
• UDI-Device Identifier: 04546540448897
• UDI-Public: (01)04546540448897
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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 Model Number: 48130000
• Device Catalogue Number: 48130000
• Device Lot Number: J3V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 10/27/2017
• 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: 50 YR
• Patient Weight: 113