MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 50 MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	482316550
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/27/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a screw had broken 3-4 months after primary surgery and revision surgery was needed to correct it.The screw was in s1.The customer reported that the patient presented with a squeak noise.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the beach marks found on the fractured surface are consistent with fatigue fractures.As the patient was described as mobile and did not fuse, it is likely fatigue from excess movement not recommended post-surgery over the 3-4 months of implantation led to the device failure.As the ifu states that implanted devices may fatigue as they are not meant to indefinitely withstand the normal loads of bone and are only meant to aid in support during fusion of the vertebrae and if the patient is involved in an occupation or activity which applies inordinate stress upon the implant the surgeon must advice the patient that resultant forces can cause failure of the device conclusion: the most likely failure is fatigue on the implant from patient activity and non-fusion.
Event or Problem Description
It was reported that a screw had broken 3-4 months after primary surgery and revision surgery was needed to correct it.The screw was in s1.The customer reported that the patient presented with a squeak noise.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 50 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: 5842983
• Report Number: 3005525032-2016-00090
• Device Sequence Number: 466824
• Product Code: MNH
• UDI-Device Identifier: 04546540562258
• UDI-Public: (01)04546540562258
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K071373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2016

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: 482316550
• Device Lot Number: B30572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 11/08/2016
• 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 Weight: 103