MAUDE Adverse Event Report: STRYKER SPINE-US XIA LP POLYAXIAL SCREW 7.5 X 55MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 03821755

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 04/27/2021

Event Type  Injury  

Event Description

A patient presented with pain, a subsequent x-ray revealed that the tulip of a xia ii lp polyaxial screw disengaged from the screw shaft post-operatively.Revision surgery was performed.

Manufacturer Narrative

B5 has been corrected with additional information following the investigation.Visual inspection was performed and it was found that there was minor deformation on the base of the tulip.There is also deformation on one side of the bulb of the shank head.Investigation of associated blocker confirms this, as the deformation shown on the bottom of blocker is tending towards one side; deformation on one side is more severe than opposite side indicating rod was not horizontally seated in tulip head.Inside of blocker is deformed as well, acute angles of hex are deformed and rounded indicating excessive torque was applied either during initial or final tightening of blocker.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.It was not reported if a torque wrench was used or not.It was not reported if fusion occurred or how long the implant was active.No patient information was reported or if patient experienced any trauma post op.Sgt and ifu were reviewed and the following was found to be relevant: in the event the rod is forced down while tightening the closure screw, be sure that the closure screw is fully engaged into the screw head.This will help resist the high reactive forces generated by the final-tightening maneuvers.Extra caution is advised when: 1) the rod is not horizontally placed into the screw head 2) the rod is high in the screw head 3) an acute convex or concave bend is contoured into the rod.Once the correction procedures have been carried out and the spine is fixed in a satisfactory position, the final tightening of the closure screw is done by utilizing the anti-torque key (03807026) and the torque wrench (03807028).The torque wrench indicates the optimum force which has to be applied to the implant for final tightening.Line up the two arrows to achieve this optimum torque of 12nm.Note: it is not recommended to exceed 12nm during final tightening.¿ delayed union or nonunion: internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant.If a nonunion develops or if the implants loosen, bend or break, the device(s) should be revised or removed immediately before serious injury occurs.The most likely cause of the reported event was determined to be incorrect placement of the rod in the tulip head during final tightening and potential use of excessive force during initial or final tightening.Other potential causes could include length of implantation, patient trauma, and/or non-union.

Event Description

A patient presented with pain, a subsequent x-ray revealed that the tulip of a xia ii lp polyaxial screw disengaged from the screw shaft post-operatively.Revision surgery was performed.Upon further investigation, it was additionally found that the xia blocker used with the screw had deformed.This record captures the screw.

• Brand Name: XIA LP POLYAXIAL SCREW 7.5 X 55MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11893646
• MDR Text Key: 252918693
• Report Number: 3005525032-2021-00024
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540149336
• UDI-Public: 04546540149336
• Combination Product (y/n): N
• PMA/PMN Number: K060361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

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
• Device Operator: No Information
• Device Model Number: 03821755
• Device Catalogue Number: 03821755
• Device Lot Number: C00895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR