MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48233540
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that the tulips of nine xia deformity uniplanar screws "released" post-operatively.Revision surgery has been performed.This report will capture the ninth of nine screws.
Event or Problem Description
It was initially reported that the tulips of nine xia deformity uniplanar screws "released" post-operatively.However, upon additional information received, it was confirmed that this only happened to 2 screw tulips.Revision surgery was performed where the screws were explanted.This report will capture the second of the two screws.
Additional Manufacturer Narrative
B5 was corrected following additional information received.Visual inspection confirmed that the tulip disengaged from the screw.Deformation was observed on shank bulb, from the rod.This deformation is on the outer edge of shank bulb, indicating extreme angulation of screw to rod contact surface.The direction of deformation also indicates that the rod axis was not in line with the uniplanar axis of the tulip.This indicated enough force may have been applied during spinal correction to force the tulip out of its intended single axis of motion.Additional deformation is seen on the screw surface where the screwdriver engages, indicating excessive stress being applied from the tulip head before disengagement.This can be confirmed by the deformation observed on the locking ring of the tulip.Deformation on locking ring is observed in more than one location, indicating multiple excessive force maneuvers, in multiple directions.Locking ring was most likely deformed during vertebral adjustment which compromised integrity of the locking ring.Additional deformation on locking ring is most likely from the tulip disengaging.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Visual inspection shows that multiple maneuvers were performed simultaneously or consecutively that put excess stress on the screw tulip.Evidence of this is shown in the multiple deformations on the tulip locking ring as well as the deformation left on the screw shank bulb, which was out of line with the tulip axis.Likely cause is due to excessive angulation and excessive force applied as seen in the deformation on the screw and tulip locking ring.

• Brand Name: XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11396623
• Report Number: 0009617544-2021-00032
• Device Sequence Number: 11546255
• Product Code: NKB
• UDI-Device Identifier: 07613327001037
• UDI-Public: 07613327001037
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 48233540
• Device Catalogue Number: 48233540
• Device Lot Number: 203044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 06/24/2021
• 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: Required Intervention
• Patient Age: 14 YR