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

Model Number	15004-095-090
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned implant is currently under investigation.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
Revision surgery was conducted on (b)(6) 2021 to remove a polyaxial screw from the patients iliac.The screw fracture & broke at the neck of the shank.
Additional Manufacturer Narrative
The initial submission was erroneously submitted with an incorrect date of event and date of this report.The explanted polyaxial screw returned for evaluation.Visible inspection reveals the screw fractured at the cam/hexalobe cross section.No defects were found at the level of breakage.Review of manufacturing records indicate the lot number met appropriate material strength requirements and critical dimensions specifications.The patient's postoperative activity level as well as bone quality is unknown.It was reported the patient is a heavy smoker.Based on information provided, the root cause cannot be determined at this time.Labeling review: "warnings/caution: risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury." "possible adverse effects: the following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation.These effects and any other known by the surgeon must be discussed with the patient preoperatively.1.Initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device component." "postoperative management: the surgeon should instruct the patient regarding amount and time frame after surgery of any weight bearing activity.The increased risk of bending, dislocation, and/or breakage of the implant devices, as well as an undesired surgical result are consequences of any type of early or excessive weight bearing, vibratory motion, fall, jolts or other movements preventing proper healing and/or fusion development.Postoperative patients should be instructed not to use tobacco or nicotine products, consume alcohol, or use non-steroidal anti-inflammatory drugs and aspirin, as determined by the surgeon.Complete postoperative management to maintain the desired result should also follow implant surgery.".

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 11416252
• Report Number: 2027467-2021-00006
• Device Sequence Number: 20011471
• Product Code: NKB
• UDI-Device Identifier: 00190376136554
• UDI-Public: (01)00190376136554(10)8329603
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K181677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 15004-095-090
• Device Catalogue Number: 15004-095-090
• Device Lot Number: 8329603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 06/05/2021
• 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: 45 YR