MAUDE Adverse Event Report: STRYKER SPINE-US 6.5X50 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482616550
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a screw migrated post-operatively.Patient underwent revision surgery on (b)(6) 2019.During revision surgery, the surgeon removed the same screw that was implanted into s1 and re-implanted at a different angle.
Event or Problem Description
It was reported that a screw migrated post-operatively.Patient underwent revision surgery on (b)(6) 2019.During revision surgery, the surgeon removed the same screw that was implanted into s1 and re-implanted at a different angle.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of manufacturing and complaint history records revealed no relevant issues or similar complaints.The patient was reported to be of a heavy weight.According to the ifu, obesity is listed as a contraindication.An overweight or obese patient can produce loads on the spinal system which can lead to failure of the fixation of the device or to failure of the device itself.As the device was not returned, a definite root cause cannot be determined, but most likely the patient's weight caused the screw to migrate as warned against in the ifu.Screw hole preparation may have also contributed as it is unknown at this time how the screws were prepped and inserted.H3 other text : device was re-implanted in the patient.

• Brand Name: 6.5X50 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8771793
• Report Number: 3005525032-2019-00069
• Device Sequence Number: 19327507
• Product Code: NKB
• UDI-Device Identifier: 07613327351552
• UDI-Public: 07613327351552
• Combination Product (Y/N): N
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 482616550
• Device Lot Number: B84091
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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