MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	482316545
Medical Device Problem Codes	Mechanical Problem (1384); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment; device history review indicated all devices released into final stock met specifications.Device evaluation could not be performed as no items were returned.Complaint history review indicated there have been no other similar complaints for this reported lot.The event could not be confirmed nor the root cause of the reported event determined because no device and/or insufficient information was provided for review.
Event or Problem Description
It was reported that; it was also discovered that the patient had migration of the peek cage, and loosening of screws.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6060620
• Report Number: 3005525032-2016-00138
• Device Sequence Number: 863082
• Product Code: KWP
• UDI-Device Identifier: 04546540562241
• UDI-Public: (01)04546540562241(11)140514(10)B43410
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 482316545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2016
• Initial Report FDA Received Date: 10/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1