MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 5.5 X 25; PEDICLE SCREW SPINAL SYSTEM

Model Number	48145525
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient received a l4-5 fusion using cortical screw trajectory.It was reported that during regular follow up, the patient x-rays showed that the screws had pulled out.It was reported that during the revision surgery it was discovered that the screw head had dislodged from the screw shaft.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: no relevant manufacturing issues were identified as all units met stryker specifications.The device was returned in 2 pieces, as the tulip head disengaged with the rest of the screw.Conclusion: the plausible root cause of the event is determined to be overtightening.
Event or Problem Description
It was reported that the patient received a l4-5 fusion using cortical screw trajectory.It was reported that during regular follow up, the patient x-rays showed that the screws had pulled out.It was reported that during the revision surgery it was discovered that the screw head had dislodged from the screw shaft.

• Brand Name: XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 5.5 X 25
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6582394
• Report Number: 0009617544-2017-00209
• Device Sequence Number: 555543
• Product Code: NKB
• UDI-Device Identifier: 04546540450159
• UDI-Public: (01)04546540450159
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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: 48145525
• Device Catalogue Number: 48145525
• Device Lot Number: 155319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2015
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: 04/25/2017
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 08/24/2017
• 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