MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 80MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	482318580
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	02/18/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the rod and the tulip dissociated from left iliac bolt.
Additional Manufacturer Narrative
Lot# b56552.Method: visual inspection; device history review; complaint history review; risk assessment.Results: the inspection revealed a large indentation on the bone screw head as well as excessive deformation on the edge of the screw head.The large indentation suggests over-torquing of the device possibly during provisional and final tightening, which is supported by the deformation observed on the tulip threads and retaining clip.Additionally the deformation on the edge of the screwhead confirms that high angulation of the screw was present.Conclusion: the most likely of the customer reported event is over-tightening of the blocker at a high angulation during the initial surgery.
Event or Problem Description
It was reported that the rod and the tulip dissociated from left iliac bolt.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 80MM
• 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: 5495913
• Report Number: 3005525032-2016-00026
• Device Sequence Number: 10831056
• Product Code: MNH
• UDI-Device Identifier: 04546540598653
• UDI-Public: (01)04546540598653
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K083393
• 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): 02/18/2016

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: 482318580
• Device Lot Number: B56552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2016
• Supplement Report FDA Received Date: 06/21/2016
• 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: 62 YR
• Patient Weight: 96