MAUDE Adverse Event Report: ALPHATEC SPINE, INC. CORTICO-CANCELLOUS SCREW 5.5 MM X 30 MM (TI-6AL-4V ELI); PEDICLE SCREW SYSTEM

Model Number	47400-055-030
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection found that the polyaxial screw had fractured and broke mid-way of the threaded shaft.Information provided by the sales rep indicated this event occurred approximately 2 years after initial implantation.Additionally, a successful fusion/fusion had not yet occurred.In this case, the construct was more than likely carrying the majority of the load throughout the time of implantation with no gradual transfer of load that would be associated with fusion/healing.Typically, a functional fusion should take 3 - 6 months, but may take up to a year.During that time as successful fusion/healing occurs, there's a gradual transfer of load reducing the amount of stress placed on the implants.These implants are intended for temporary stabilization until fusion occurs they do not have an indefinite life and may fail over time if fusion is not achieved.The supplied instructions for use (ins-076) provide a warning to aid in reducing this type of event.Warnings: the system implants are used only to provide temporary internal fixation during the bone fusion process with the assistance of a bone graft.A successful result may not be achieved in every instance of use with these devices.Without solid bone fusion, these devices cannot be expected to support the spine indefinitely and may fail due to bone-metal interface, rod failure or bone failure.
Event or Problem Description
Revision surgery was conducted on (b)(6) 2018.During the revision, for an unrelated issue (patient condition, non-union), the screw located at the left l5 was found broken.The construct was originally implanted on (b)(6) 2016 at the l4-l5 using cbx.The cbx cortical screws were removed and replaced with arsenal screws from the l3 - l5.

• Brand Name: CORTICO-CANCELLOUS SCREW 5.5 MM X 30 MM (TI-6AL-4V ELI)
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 7540398
• Report Number: 2027467-2018-00031
• Device Sequence Number: 16568456
• Product Code: NKB
• UDI-Device Identifier: 00844856091757
• UDI-Public: (01)00844856091757
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 47400-055-030
• Device Catalogue Number: 47400-055-030
• Device Lot Number: 698270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/24/2018
• 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: Other
• Patient Age: 57 YR