MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 70MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482318570
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	04/26/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; pelvic screw was used on a l2 to the pelvis revision surgery on (b)(6) 2016.Doctor called me and said the head has separated from the screw.
Additional Manufacturer Narrative
Lot# b54857 method: visual inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual inspection of the device confirmed that the device had been over-tightened during final tightening.Conclusion: the most likely cause of the customer reported event is over-tightening.
Event or Problem Description
It was reported that; pelvic screw was used on a l2 to the pelvis revision surgery on (b)(6) 2016.Doctor called me and said the head has separated from the screw.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 70MM
• 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: 5680635
• Report Number: 3005525032-2016-00060
• Device Sequence Number: 18874779
• Product Code: MNH
• UDI-Device Identifier: 04546540598646
• UDI-Public: (01)04546540598646
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 04/29/2016

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: 482318570
• Device Lot Number: B54857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2016
• Supplement Report FDA Received Date: 09/08/2016
• 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 Age: 68 YR
• Patient Weight: 53