MAUDE Adverse Event Report: STRYKER SPINE-US XIA BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	03756230
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, screws slips off after tighten hexagon thread using crown-opener.Trying to loosen it and re-installed would occur a problem that hexagon thread becoming too slippery to install.Surgery was successfully completed using back-up blockers.Surgical delay of 5 min was reported.No adverse consequence to the patient was reported.
Event or Problem Description
It was reported that during surgery, screws slips off after tighten hexagon thread using crown-opener.Trying to loosen it and re-installed would occur a problem that hexagon thread becoming too slippery to install.Surgery was successfully completed using back-up blockers.Surgical delay of 5 min was reported.No adverse consequence to the patient was reported.
Additional Manufacturer Narrative
Method: product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed via correspondence with sales rep.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Product was not received back so an evaluation was not possible.Upon complaint history review and nc/capa history review, no relevant complaints/ nc/capa were identified.It was reported that the blocker appeared to be cross-threaded with the tulip head.Conclusion: the most likely cause of the reported event was determined to be cross threading of blocker with tulip head resulting in difficult assembly.Device not returned.

• Brand Name: XIA BLOCKER
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8094226
• Report Number: 3005525032-2018-00073
• Device Sequence Number: 19168935
• Product Code: NKB
• UDI-Device Identifier: 04546540147257
• UDI-Public: 04546540147257
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: 03756230
• Device Lot Number: 9Y4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1