MAUDE Adverse Event Report: STRYKER SPINE-US 9.5X90 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482619590
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the screw was broken post-operatively.A revision surgery will be required to replace the screw.
Additional Manufacturer Narrative
Visual, dimensional, functional and materials analysis could not be performed as the device remains implanted in patient.Complaint history review for similar events and device history records could not be performed as a valid lot code was not provided and could not be obtained.It was reported that the patient will undergo revision surgery due to two screws fracturing post-operatively several days after the initial procedure.The screws were not inspected before-hand as there was no visible damage.No additional information, photos, or x-rays were provided.It is unknown when the revision surgery will occur.There is not enough information provided and the devices were not returned to confirm the failure mode nor determine a root cause.From the ifu: the surgeon must warn the patient of the surgical risks and make aware of possible adverse effects.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.Patients who smoke have been shown to have an increased incidence of non-unions.Surgeons must advise patients of this fact and warn of the potential consequences.For diseased patients with degenerative disease, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance.In such cases, orthopaedic devices may be considered only as a delaying technique or to provide temporary relief.
Event or Problem Description
It was reported that the screw was broken post-operatively.A revision surgery will be required to replace the screw.

• Brand Name: 9.5X90 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8467480
• Report Number: 3005525032-2019-00031
• Device Sequence Number: 11253371
• Product Code: NKB
• UDI-Device Identifier: 07613327351576
• UDI-Public: 07613327351576
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 482619590
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 03/30/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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