MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	03829640
Medical Device Problem Codes	Mechanical Jam (2983); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after implanting a xia deformity reduction long arm polyaxial screw 6.5 x 40mm at s1, the surgeon attempted to remove a and replace with a larger diameter screw intra-operatively.There was difficulty removing the screw resulting in a surgical delay of more than one hour.Once removed, it was discovered that the end of the screw was separated from the shaft rod.No adverse consequences or harm to the patient were reported.
Additional Manufacturer Narrative
Visual inspection: the tulip head is overextended on the screw shank bulb, causing it to be jammed and angulated on the bulb.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.It was reported that the screwdriver was used to remove the screw.After the tulip jammed, pliers were used to remove.The level at s1 was not a difficult angle.The screwdriver was not misaligned with the screw and the surgeon did not appear to apply excessive force.The bone quality was good.The tulip head overextended on the screw shank bulb, causing it to be jammed and angulated on the bulb.Although the surgeon reportedly did not apply excessive force or misalign the screwdriver, possible root causes for this include excessive force applied during removal, overangulation of the screw and/or screwdriver not fully engaged with the screw.
Event or Problem Description
It was reported that after implanting a xia deformity reduction long arm polyaxial screw 6.5 x 40mm at s1, the surgeon attempted to remove a and replace with a larger diameter screw intra-operatively.There was difficulty removing the screw resulting in a surgical delay of more than one hour.Once removed, it was discovered that the end of the screw was separated from the shaft rod.No adverse consequences or harm to the patient were reported.

• Brand Name: XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10125068
• Report Number: 0009617544-2020-00079
• Device Sequence Number: 2464247
• Product Code: NKB
• UDI-Device Identifier: 07613154407880
• UDI-Public: 07613154407880
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K061854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03829640
• Device Catalogue Number: 03829640
• Device Lot Number: 184238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other