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 Codes	Material Separation (1562); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tulips of 2 xia uniplanar screws disengaged from their respective screw shafts intra-operatively.Subsequently, there was a 60 minute delay to surgery as the surgeon removed the screws and rods on both sides to redo the construct.The procedure was completed successfully.This report captures the first of the two screws.
Event or Problem Description
It was reported that the tulips of 2 xia uniplanar screws disengaged from their respective screw shafts intra-operatively.Subsequently, there was a 60 minute delay to surgery as the surgeon removed the screws and rods on both sides to redo the construct.The procedure was completed successfully.This report captures the first of the two screws.
Additional Manufacturer Narrative
The device has been received and upon receipt d4 (lot #) has been corrected from '190449' to '197153'.
Additional Manufacturer Narrative
B.5 has been corrected following new information received and investigation completion.Visual inspection confirmed that tulip did not disengage and that there is no deformation on this product.Report 0009617544-2021-00067 addresses the complaint of the tulip disengagement, as visual inspection confirmed that the tulip did disengage in that record.
Event or Problem Description
It was initially reported that the tulips of 2 xia uniplanar screws disengaged from their respective screw shafts intra-operatively.However, after additional information received and investigation completion, 8 screw tulips disengaged.Subsequently, there was a 60 minute delay to surgery as the surgeon removed the screws and rods on both sides to redo the construct.The procedure was completed successfully.This report captures the first returned screw which shows no signs of tulip disengagement.

• 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: 11721013
• Report Number: 0009617544-2021-00066
• Device Sequence Number: 19791474
• Product Code: NKB
• UDI-Device Identifier: 07613327001037
• UDI-Public: 07613327001037
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K142381
• 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): 07/12/2021

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: 48233540
• Device Catalogue Number: 48233540
• Device Lot Number: 197153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 05/04/2021; 06/29/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 05/25/2021; 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1