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); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that the tulips of 9 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 sixth of the nine screws.
Additional Manufacturer Narrative
B.5 has been corrected following new information received and investigation completion.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records could not be reviewed as a valid lot code was not provided and could not be obtained.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker.If devices and / or additional information become available, this investigation will be reopened.An investigation was done for one of the two returned screws which did exhibit tulip disengagement.Summary of this investigation is below: "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".Due to the implant not being returned the root cause could not be determined conclusively, however it was most likely due to similar causes as the returned screw.
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 fourth of the eight screws.

• 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: 11881467
• Report Number: 0009617544-2021-00097
• Device Sequence Number: 11683697
• Product Code: NKB
• UDI-Device Identifier: 07613327001020
• UDI-Public: 07613327001020
• 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
• 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: 48233535
• Device Catalogue Number: 48233535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1