MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482317540
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the tulip head separated from the screw while reducing a spondy with the corkscrew persuader.
Additional Manufacturer Narrative
Results: visual inspection of the blocker confirmed signs of overtightening, with rod indentations present on both sides of the blocker, which further supports the root cause.Visual inspection of the rod further confirmed overtightening of the blocker, due to material wear from the blocker pressing into the rod and material wear from the rod pressing into the tulip visible on the rod.Additional forces may have rotated the tulip relative to the bone screw and caused the separation of the tulip from the bone screw.Conclusion: the root cause was determined to be both over-tightening of the blockers past 12nm and reduction of rod while blockers were over-tightened.
Event or Problem Description
It was reported that; the tulip head separated from the screw while reducing a spondy with the cork screw persuader.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 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: 5537687
• Report Number: 3005525032-2016-00030
• Device Sequence Number: 10858514
• Product Code: NKB
• UDI-Device Identifier: 04546540562340
• UDI-Public: (01)04546540562340
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• 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): 03/07/2016

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: 482317540
• Device Lot Number: A73144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2016
• 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
• Patient Age: 43 YR