MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW 10.5 X 90MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482311590
Medical Device Problem Codes	Disassembly (1168); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; doing a revision case the head of a 10.5x90 screw the head came off.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assesment.Result: visual inspection on the returned device showed locking clip deformation and some scuff marks which imply application of additional force while adjusting the screw head via corkscrew persuader.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the probable root cause of the event is likely to be user error- application of excess force.
Event or Problem Description
It was reported that: doing a revision case the head of a 10.5x90 screw the head came off.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 10.5 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: 5769466
• Report Number: 3005525032-2016-00074
• Device Sequence Number: 622910
• Product Code: MNH
• UDI-Device Identifier: 04546540598844
• UDI-Public: (01)04546540598844
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2016

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: 482311590
• Device Lot Number: B30378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2016
• Supplement Report FDA Received Date: 09/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1