MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 8.5 X 90MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	4823718590
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the third surgery of extraction due to l3/4 screw loosening and pseudoarthrosis was performed.And then th10-s2ai were fixed with screws.
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 specifications.The patient activity level is unknown.Conclusion: the root cause cannot be determined conclusively.
Event or Problem Description
It was reported that the third surgery of extraction due to l3/4 screw loosening and pseudoarthrosis was performed.And then th10-s2ai were fixed with screws.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 8.5 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: 5981889
• Report Number: 3005525032-2016-00118
• Device Sequence Number: 1397691
• Product Code: MNH
• UDI-Device Identifier: 07613252045861
• UDI-Public: (01)07613252045861
• Combination Product (Y/N): N
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2016

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: 4823718590
• Device Lot Number: B54353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2016
• Supplement 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
• Patient Age: 83 YR