MAUDE Adverse Event Report: ALPHATEC SPINE, INC. SET SCREW (TI-6AL-4V ELI); PEDICLE SCREW SYSTEM

Model Number	47127
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The implants have not been returned nor has the identifying lot number been provided.Multiple attempts to obtain information have been unsuccessful.Upon the receipt of additional information or the product in question, a follow-up report will be submitted.
Event or Problem Description
After suffering from a fall, patient returned for a 6 month post-op visit.Films taken at the time showed the locking screw(s) had come off the tulip of the pedicle screw.Additionally, the battalion interbody also fractured and backed out into the foramen.Revision surgery was conducted (b)(6) 2018.The arsenal spinal fixation system was originally implanted in (b)(6) 2017.

• Brand Name: SET SCREW (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: 8000412
• Report Number: 2027467-2018-00077
• Device Sequence Number: 13740873
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582
• 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): 09/25/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2018
• 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