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

Model Number 48233535

Device Problems Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

Status and location of the device is unknown.

Event 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 sixth of nine screws.

Event 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.

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.

• Brand Name: XIA DEFORMITY UNIPLANAR SCREW DIAM 5.5 X 35 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11396593
• MDR Text Key: 234226756
• Report Number: 0009617544-2021-00029
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327001020
• UDI-Public: 07613327001020
• Combination Product (y/n): N
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48233535
• Device Catalogue Number: 48233535
• Device Lot Number: 197556
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR