MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 35 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48233535
Medical Device Problem Codes	Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)
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 seventh of nine screws.
Additional Manufacturer Narrative
B5 was updated to reflect the additional information received.After evaluating x-ray provided, it is noted that not all 9 tulips disengaged as previously reported.Seven of the nine screws have no issue and were not returned.Tulip disengagement can be seen on x-ray in 2 screws and are captured in mfr report #0009617544-2021-00025 and 0009617544-2021-00032.There was no alleged issue with this screw.
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 two screws were explanted.There was no alleged issue with this screw.

• Brand Name: XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 35 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11396596
• Report Number: 0009617544-2021-00030
• Device Sequence Number: 14235952
• Product Code: NKB
• UDI-Device Identifier: 07613327001020
• UDI-Public: 07613327001020
• 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: 48233535
• Device Catalogue Number: 48233535
• Device Lot Number: 197556
• Was Device Available for Evaluation?: No
• 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