MAUDE Adverse Event Report: STRYKER SPINE-US XIA LP POLYAXIAL SCREW 7.5 X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTE

Model Number	03821750
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when a screw was implanted in the right s1 pedicle, after attaching rod to the saddle with a blocker - during manipulation of distraction to complete discectomy and interbody device placement, the tulip separated from the screw shank.It was discovered during x-ray of post implantation of interbody device.Screw was then removed with poly head adjuster driver, and replaced with another screw.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Visual analysis, device history review, complaint history review, risk assessment; result: the reported event of a screw tulip disengagement was confirmed via visual inspection.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The screw was returned in 2 pieces as the tulip head was disengaged from the main screw shank.There was deformation on the bottom of the tulip head and on the screw shank head.Per correspondence with the sales rep, the surgeon appeared to apply excessive force during the compression of the construct post inter-body implantation.Conclusion: the probable root cause of the reported event was determined to be user error- excessive compressive force applied.
Event or Problem Description
It was reported that when a screw was implanted in the right s1 pedicle, after attaching rod to the saddle with a blocker during manipulation of distraction to complete discectomy and interbody device placement, the tulip separated from the screw shank.It was discovered during x-ray of post implantation of interbody device.Screw was then removed with poly head adjuster driver, and replaced with another screw.There were no adverse consequences to the patient.
Event or Problem Description
It was reported that when a screw was implanted in the right s1 pedicle, after attaching rod to the saddle with a blocker - during manipulation of distraction to complete discectomy and interbody device placement, the tulip separated from the screw shank.It was discovered during x-ray of post implantation of interbody device.Screw was then removed with poly head adjuster driver, and replaced with another screw.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
The device was received on 05/14/2018.Section corrected.Section updated with return date.

• Brand Name: XIA LP POLYAXIAL SCREW 7.5 X 50MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7493405
• Report Number: 3005525032-2018-00035
• Device Sequence Number: 18860163
• Product Code: NKB
• UDI-Device Identifier: 04546540149329
• UDI-Public: (01)04546540149329
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/30/2018

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: Health Professional
• Device Model Number: 03821750
• Device Catalogue Number: 03821750
• Device Lot Number: D36828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 05/10/2018; 07/09/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 06/06/2018; 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1