MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 7.5 X 80MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	4823717580
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; tulip head broke off screw while inserting blocker.Update: all of the broken fragments were retrieved from the surgical site.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Unanticipated hazard.Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The reported event occurred while doctor was using a standard blocker inserter.No persuader was being used by the surgeon according to communication with the sales representative.Surgical technique states the blocker is assembled onto the universal tightener for insertion.Conclusion: a definitive root cause of the event could not be determined with the given information.
Event or Problem Description
It was reported that; tulip head broke off screw while inserting blocker.Update: all of the broken fragments were retrieved from the surgical site.There were no adverse consequences to the patient.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW MEDIAL BIASED 7.5 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: 5648310
• Report Number: 3005525032-2016-00052
• Device Sequence Number: 10816322
• Product Code: NKB
• UDI-Device Identifier: 07613252045793
• UDI-Public: (01)07613252045793
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2016

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: 4823717580
• Device Lot Number: B33429
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2016
• Supplement Report FDA Received Date: 09/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1