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

Model Number	17412
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an mis tlif l4-l5 surgery, the surgeon attempted to "pop" on the loaded extended tab tulip at l5, but it would not go on.Another attempt was made at l4 without success.The tulip was switched out and the new one deployed normally at l4.A second attempt was made at l5, but the tulip would not go on.The surgeon was able to switch out the shank for an assembled screw at l5 with no further issues.It was reported this added 30-40 minutes to the surgery.Upon cleanup the following day, the inserters used during surgery were inspected and seemed "jammed".One of the extended tab tulips looked like the ring had been deployed and wouldn't attach to the shank.The other tulip heads "popped" on the shank but couldn't be deployed as both inserters were not working.
Additional Manufacturer Narrative
The implants nor the device returned for evaluation.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.If additional information is received, a supplemental report will be submitted.

• 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
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008
• MDR Report Key: 14599061
• Report Number: 2027467-2022-00037
• Device Sequence Number: 5562665
• Product Code: NKB
• UDI-Device Identifier: 00190376270241
• UDI-Public: 00190376270241
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 17412
• Device Catalogue Number: 17412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown