MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 55 MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	482317555
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screw potentially damaged interoperatively, preventing use.The head of the screw was discovered by surgeon dislodged from the shaft.Screw was removed and replaced with similar screw from same system.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Inspection of the device confirmed that the bone screw head had shown asymmetrical deformation that was larger than expected of a 12 nm tightening torque.Conclusion: the most likely cause of the customer reported event is the over stressing of the implants due to the surgeon's multiple tightening attempts and persuasion actions.
Event or Problem Description
It was reported that a screw potentially damaged intraoperatively, preventing use.The head of the screw was discovered by surgeon dislodged from the shaft.Screw was removed and replaced with similar screw from same system.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 55 MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6055206
• Report Number: 3005525032-2016-00136
• Device Sequence Number: 434264
• Product Code: KWP
• UDI-Device Identifier: 04546540562371
• UDI-Public: (01)04546540562371
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K071373
• 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): 01/19/2017

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: 482317555
• Device Lot Number: A84064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2016
• Supplement Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR