MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW CLOSED HEAD 7.5 X 90MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	482377590
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	11/11/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2012, the patient underwent the surgery.The pain and an abnormal noise occurred to the patient's iliac.The surgeon confirmed x-ray.And he found that the rod of s2ai (right) loosened.Therefore the patient underwent the revision surgery(screw and rod removed) on (b)(6) 2016.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: upon device evaluation it was found that the set screw was disengaged from the screw.No relevant manufacturing issues were identified as all units met stryker specifications.Conclusion: the exact root cause cannot be determined conclusively, hence is multifactorial.
Event or Problem Description
It was reported that on (b)(6) 2012, the patient underwent the surgery.The pain and an abnormal noise occurred to the patient's iliac.The surgeon confirmed x-ray.And he found that the rod of s2ai(right) loosened.Therefore the patient underwent the revision surgery(screw and rod removed) on (b)(6) 2016.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW CLOSED HEAD 7.5 X 90MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6148656
• Report Number: 3005525032-2016-00152
• Device Sequence Number: 18926499
• Product Code: MNH
• UDI-Device Identifier: 07613327002799
• UDI-Public: (01)07613327002799
• Combination Product (Y/N): N
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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 Catalogue Number: 482377590
• Device Lot Number: B12287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 05/24/2017
• 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
• Patient Age: 78 YR