MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 5.5 X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482365540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Broken pedical screw was removed from l1 on left side.Blocker came loose from pedical screw on l1 on right side.Pedical screw on right was also removed.New pedicle screws were placed on both sides at l2 and 4 connectors were used to connect l2 to existing rod.
Event or Problem Description
Broken pedical screw was removed from l1 on left side.Blocker came loose from pedical screw on l1 on right side.Pedical screw on right was also removed.New pedical screws were placed on both sides at l2 and 4 connectors were used to connect l2 to existing rod.
Event or Problem Description
Broken pedical screw was removed from l1 on left side.Blocker came loose from pedical screw on l1 on right side.Pedical screw on right was also removed.New pedical screws were placed on both sides at l2 and 4 connectors were used to connect l2 to existing rod.
Additional Manufacturer Narrative
Method: visual inspection, material analysis, product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the customer reported event was confirmed via visual inspection.The returned screw was confirmed to be fractured at the screw shank.The fractured piece was not returned.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It is unknown if any patient factors could have contributed to the event such as bone quality, post op activity, or patient fall.Material analysis was performed and the reported screw was confirmed to fracture through fatigue.However, it is unknown what lead up to the fatigue fracture due to a lack of information.It is possible the loose blocker(lack of the blocker final tightening) caused excess strain onto the screw which eventually lead to a fatigue fracture.Patient factors, length of implantation, fusion, and type of fixation construct could have also contributed to the event.Conclusion: the root cause cannot be determined conclusively due to insufficient information.

• Brand Name: XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 5.5 X 40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7912279
• Report Number: 0009617544-2018-00233
• Device Sequence Number: 856767
• Product Code: MNH
• UDI-Device Identifier: 07613327001358
• UDI-Public: 07613327001358
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2018

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: No Information
• Device Catalogue Number: 482365540
• Device Lot Number: 163725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 10/11/2018; 11/28/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 11/07/2018; 12/06/2018
• 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