MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 6.5 X 70; PEDICLE SCREW SPINAL SYSTEM

Model Number	48146570
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	03/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; after the first operation it was determined that the heads of the screw were removed from the screw in the result of the patient's application to the clinic with the pain and it was changed with the screws in the revision surgery.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the screw was returned in 2 pieces as the tulip head was disengaged from the main screw body.No relevant manufacturing issues were identified as all units met specifications conclusion: the plausible root cause of the event is determined to be overtightening putting additional stress on the construct lead to tulip disengagement.
Event or Problem Description
It was reported that; after the first operation it was determined that the heads of the screw were removed from the screw in the result of the patient's application to the clinic with the pain and it was changed with the screws in the revision surgery.

• Brand Name: XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 6.5 X 70
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6518607
• Report Number: 0009617544-2017-00165
• Device Sequence Number: 788338
• Product Code: NKB
• UDI-Device Identifier: 04546540450319
• UDI-Public: (01)04546540450319
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2017

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: 48146570
• Device Catalogue Number: 48146570
• Device Lot Number: 119123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 08/22/2017
• 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: 7 YR
• Patient Weight: 25