MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM; PEDICLE SCREW SPINAL SYSTEM

Model Number	482317545
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the surgeon, reported that the patient underwent revision of unknown spine implants / screw.The patient presented with issues / possibly pain.The surgeon decided to undertake revision surgery to reposition a screw which was either not positioned optimally or had moved following original implantation in 2016.The patient's bone quality was described as poor.The surgeon is not citing the implant as the reason for the revision.
Additional Manufacturer Narrative
Method: product history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The product was not returned as it remains implanted and is unavailable for evaluation.Conclusion: the plausible root cause of the event is determined to be incorrect trajectory for screw insertion along with poor bone quality leading to screw migration due to stress on implant because of active loading.
Event or Problem Description
It was reported that; the surgeon, reported that the patient underwent revision of unknown spine implants / screw.The patient presented with issues / possibly pain.The surgeon decided to undertake revision surgery to reposition a screw which was either not positioned optimally or had moved following original implantation in 2016.The patient's bone quality was described as poor.The surgeon is not citing the implant as the reason for the revision.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM
• 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: 6713812
• Report Number: 3005525032-2017-00079
• Device Sequence Number: 13713131
• Product Code: MNH
• UDI-Device Identifier: 04546540562357
• UDI-Public: (01)04546540562357
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K113666
• 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): 10/16/2017

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: 482317545
• Device Catalogue Number: 482317545
• Device Lot Number: B10021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 10/16/2017
• 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