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

Model Number 15100

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2022

Event Type  Injury  

Event Description

During a postoperative visit, a radiograph revealed a set screw backed out.Revision surgery has not been planned.The surgeon will continue to monitor the patient.

Manufacturer Narrative

The implant remains in situ.The identifying part and lot number was not provided; therefore, a review of the device history records could not be performed.The root cause could not be determined at this time.If additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

D6.Explanted: (b)(6) 2022.H6.Health impact: 4629.Investigation findings: 3221.Conclusion: 22.On (b)(6) 2022, the sales representative reported a revision surgery took place the prior week.During the revision, the only item explanted was the set screws.The hospital will not release the explanted implants to return to alpahtec at this time.The sales rep did a visual inspection of the explanted set screws and did not find any frays or damaging characteristics to the set screws or the threads.The root cause cannot be determined at this time.If the explanted set screws return to alphatec, a supplemental report will be submitted upon completion of the investigation.

• Brand Name: INVICTUS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 14493040
• MDR Text Key: 292579117
• Report Number: 2027467-2022-00034
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190376137902
• UDI-Public: 00190376137902
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 15100
• Device Catalogue Number: 15100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male