MAUDE Adverse Event Report: ALPHATEC SPINE INC INVICTUS SPINAL FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	15004-095-080
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The implants have not been returned nor have the identifying lot number(s) been provided.
Event or Problem Description
Revision surgery was conducted on (b)(6) 2020 to remove and replace two iliac screws.One had fracture and broke just below the tulip/head, and the tulip on the other splayed causing the set screw to fall out.The invictus spinal fixation system was originally implanted on (b)(6) 2019.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad, ca
• MDR Report Key: 10092841
• Report Number: 2027467-2020-00026
• Device Sequence Number: 14288448
• Product Code: NKB
• UDI-Device Identifier: 00190376136530
• UDI-Public: (01)00190376136530
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2020

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: 15004-095-080
• Device Catalogue Number: 15004-095-080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/27/2020
• 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: 81 YR