MAUDE Adverse Event Report: ALPHATEC SPINE, INC. SACRAL POLYAXIAL SCREW, 6.5 MM X 55 MM (TI-6AL-4V ELI); PEDICLE SCREW SYSTEM

Model Number	47100-065-055
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although the explanted screws have been discarded by the user facility, information provided by the sales rep indicate that its likely successful fusion had not yet occurred.Revision surgery to remove and replace the screws, and to add additional graft took place approximately 1 year & 7 months after initial implantation.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.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 took place on (b)(6) 2018 to remove & replace two broken 6.5mm sacral screws.The arsenal spinal fixation system was originally implanted on (b)(6) 2017.

• Brand Name: SACRAL POLYAXIAL SCREW, 6.5 MM X 55 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: 8000064
• Report Number: 2027467-2018-00073
• Device Sequence Number: 13740886
• Product Code: NKB
• UDI-Device Identifier: 00844856078864
• UDI-Public: (01)00844856078864
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2018

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 Model Number: 47100-065-055
• Device Catalogue Number: 47100-065-055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/24/2018
• 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: Hospitalization
• Patient Age: 68 YR