MAUDE Adverse Event Report: ALPHATEC SPINE INC POLYAXIAL POSTERIOR THORACIC SCREW, Ø3.5 MM X 16 MM (TI-6AI-4V ELI); SOLANAS POSTERIOR STABILIZATION SYSTEM

Model Number	63035-16
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	08/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The two additional polyaxial screw reported are of the same product part number/description, but contain separate manufacturing lot numbers.676395 manufactured 6/17/2014; 671596 manufactured 3/11/2014.A review of the device history records revealed no manufacturing, processing or design related irregularities.The implants were found to be properly manufactured and released according to design specifications.No irregularities have been identified.Visual inspection found that all three (3) screws fractured and broke mid-way of the threaded shaft.It may be possible because revision surgery to remove and replace the screws took place approximately 5 months after initial implantation, a successful fusion/healing may not have begun to occur.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-012) provide a warning to aid in reducing this type of event.
Event or Problem Description
An international customer ((b)(6)) reported that a young male patient with good bone quality underwent revision surgery to remove and replace 3 broke solanas screws on (b)(6) 2016.The screws fractured broke mid-way of the threaded shaft at the c6 and c7.The proximal sections of the screws were removed without issue, while the distal threaded portions remain entrapped within the patients c6/c7 cervical vertebrae's.The solanas fixation system was originally implanted on (b)(6) 2016.

• Brand Name: POLYAXIAL POSTERIOR THORACIC SCREW, Ø3.5 MM X 16 MM (TI-6AI-4V ELI)
• Common Device Name: SOLANAS POSTERIOR STABILIZATION SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 6170634
• Report Number: 2027467-2016-00102
• Device Sequence Number: 184945
• Product Code: KWP
• UDI-Device Identifier: 00844856006607
• UDI-Public: 00844856006607
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K052201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2016

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: 63035-16
• Device Catalogue Number: 63035-16
• Device Lot Number: 633760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2016
• Initial Report FDA Received Date: 12/13/2016
• 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