MAUDE Adverse Event Report: STRYKER SPINE-US 9.5X60 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482619560
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during revision surgery to correct the fixation, a xia serrato screw at s2 had fractured post-operatively.The fractured piece was removed but the screw shaft remains inside the patient.Fusion had not been achieved.
Event or Problem Description
It was reported that during revision surgery to correct the fixation, a xia serrato screw at s2 had fractured post-operatively.The fractured piece was removed but the screw shaft remains inside the patient.Fusion had not been achieved.
Additional Manufacturer Narrative
Visual inspection: the tulip was returned with the fractured shank bulb still attached inside of it.The rest of the screw shank was not returned.The shank was fractured at the bulb.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.From the ifu: 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 screw was implanted for over a year and the patient had a non union.Additionally, the bone quality was poor due to a patient infection that could cause instability in the construct.The likely cause is multifactorial with these factors likely contributing to the event.

• Brand Name: 9.5X60 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11094942
• Report Number: 3005525032-2020-00049
• Device Sequence Number: 13664546
• Product Code: NKB
• UDI-Device Identifier: 07613327352320
• UDI-Public: 07613327352320
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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
• Operator of Device: Health Professional
• Device Model Number: 482619560
• Device Catalogue Number: 482619560
• Device Lot Number: B82453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 04/27/2021
• 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