MAUDE Adverse Event Report: ALPHATEC SPINE INC TI CANNULATED POLYAXIAL SCREW 6.5 MM X 35 MM (TI-6AI-4V ELI); PEDICLE SCREW SYSTEM

Model Number	73865-35
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/23/2016
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.Although the explanted proximal section of the screw has not been returned for evaluation, information provided indicated it's likely that successful fusion had not yet occurred.Revision surgery to remove & replace the screw took place approximately 3 years after initial implantation.It appears 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 ((b)(4)) provide a warning to aid in reducing this type of event.Warnings: 2.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.
Event or Problem Description
An international customer ((b)(6)) reported a patient had been feeling a strange pain.X-rays confirmed a previously implanted screw had fractured and broke.Revision surgery was conducted on (b)(6) 2016 to remove and replace the broken cannulated screw located at the patients left s1.The proximal section was removed without issue, while approximately 15mm of the distal threaded portion remains entrapped within the patients sacrum (s1).The 2-level illico construct was originally implanted on (b)(6) 2013 during a mis-tlif from the l5-s1.

• Brand Name: TI CANNULATED POLYAXIAL SCREW 6.5 MM X 35 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: 5963841
• Report Number: 2027467-2016-00071
• Device Sequence Number: 839237
• Product Code: NKB
• UDI-Device Identifier: 00844856043183
• UDI-Public: 00844856043183
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2016

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: 73865-35
• Device Catalogue Number: 73865-35
• Device Lot Number: 649365
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2016
• Initial Report FDA Received Date: 09/20/2016
• 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
• Patient Age: 42 YR