MAUDE Adverse Event Report: ALPHATEC SPINE INC SACRAL CANNULATED POLYAXIAL SCREW 6.5 MM X 50 MM (TI-6AI-4V ELI); PEDICLE SCREW SYSTEM

Model Number	73965-40
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records revealed no manufacturing, processing or design related irregularities.The implant was found to be properly manufactured and released according to design specifications.No irregularities have been identified.Visual inspection found that the illico screw fractured and broke mid-way of the threaded shaft.Because the revision surgery took place 1 year after initial implantation, it is likely that a successful fusion had not yet occurred.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.As 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-028) provide a warning to aid in reducing this type of event.Warnings: the illico mis posterior fixation 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.The illico mis posterior fixation system is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.When used for a minimally invasive posterior approach, illico mis instrumentation is used in conjunction with polyaxial screw components.The implants are manufactured from surgical grade titanium alloy (ti-6al-4v eli or ti-6al-4v).The rods are available in commercially pure (cp) titanium and/or cobalt chrome.
Event or Problem Description
A patient returned in (b)(6) 2016 for a post-op visit and reported having pain.X-rays taken at the time confirmed the illico screw located at the s1 had fractured and broke.Revision surgery was conducted on (b)(6) 2016 to remove the fractured 6.5mm screw and replace it with a 7.5mm.The illico posterior fixation system was originally implanted at the l5-s1 in (b)(6) 2015.

• Brand Name: SACRAL CANNULATED POLYAXIAL SCREW 6.5 MM X 50 MM (TI-6AI-4V ELI)
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5721338
• Report Number: 2027467-2016-00036
• Device Sequence Number: 13453461
• Product Code: NKB
• UDI-Device Identifier: 00844856043299
• UDI-Public: 00844856043299
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K123623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2016

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: Physician
• Device Model Number: 73965-40
• Device Catalogue Number: 73965-40
• Device Lot Number: 655179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2016
• Initial Report FDA Received Date: 06/13/2016
• 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