MAUDE Adverse Event Report: STRYKER SPINE-US REDUCTION POLYAXIAL SCREW 6.5X45; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482626545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that a serrato reduction polyaxial screw fractured post-operatively.Images confirm screw has been explanted, no further information has been provided.
Additional Manufacturer Narrative
Section b5 was corrected from 'it was reported that a serrato reduction polyaxial screw fractured post-operatively.Images confirm screw has been explanted, no further information has been provided.' to 'it was reported that a serrato reduction polyaxial screw fractured post- operatively.Revision surgery was performed where the screw was removed and the construct was extended.' visual, dimensional, material and functional analysis could not be performed as the device was not returned.Photos were provided showing the screw fractured at the threaded section on the shaft.The fractured portion was reported to be left in the patient.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.From the xia instructions for use: the surgeon must warn the patient that the devices cannot and do not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implants can break or become damaged as a result of strenuous activity or trauma, and that the devices may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the devices.As the screw was not returned, a definite root cause cannot be determined.As the patient's activity level is unknown, excessive post op activity level or not following the surgeon's recommendations could have contributed to the event.Other possible root causes include excessive torque on the device, poor fixation construct, improper rod bending, and/or screw being too proud.
Event or Problem Description
It was reported that a serrato reduction polyaxial screw fractured post-operatively.Revision surgery was performed where the screw was removed and the construct was extended.

• Brand Name: REDUCTION POLYAXIAL SCREW 6.5X45
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9527574
• Report Number: 0009617544-2019-00150
• Device Sequence Number: 399382
• Product Code: NKB
• UDI-Device Identifier: 07613327351880
• UDI-Public: 07613327351880
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: 482626545
• Device Catalogue Number: 482626545
• Device Lot Number: 187889
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 03/04/2020
• 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
• Patient Age: 70 YR