MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 15054-065-040;15100

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 02/02/2023

Event Type  Injury  

Event Description

Around 4-weeks postoperatively, a set screw had become disengaged.A revision surgery was performed to remove the hardware.It was reported the thread of the screw was damaged.

Manufacturer Narrative

The returned implants are currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.

Manufacturer Narrative

H3.Pn 15054-05-040 ln ap0036: 1/18/2022 pn 15100 ln ap00820: 08/12/2022 h6.Investigation findings: 3243 investigation conclusions: 61 h10.Review of the device history record for the fixed screw, 06.5 x 40mm (pn 15054-065-04 ln ap00436) indicates the implants conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.There were no issues during the manufacture of this product that would contribute to this complaint condition.Review of the device history record for qty 3 set screws (pn 15100 ln ap00820) indicates the implants conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.There were no issues during the manufacture of this product that would contribute to this complaint condition.The fixed screw pn 15054-065-040 was returned with wear patterns observed on the rod slot, external body of the tulip, and the proximal helical flange thread.The proximal helical flange is damaged and there is wear on the single side of rod slot.The three set screws pn 15100 returned with displayed wear on the underside (rod-interfacing side) face as well as a deformed dimple feature.The sweeping wear patterns are a result of the set screw smearing against the implanted rod during set screw driving and final tightening.Root cause and failure mode: non-normal rod-tulip interface the most likely cause of the set screw backout and eventual dislocation is due to a non-normal rod to tulip interface caused by insufficient rod contouring at the tulip interface.The rod slot face on the returned fixed screw displays wear on only one side, indicative of single sided engagement between the rod and screw (i.E.Non-normal interface).The wear patterns of set screw 1 also support an asymmetric loading where the left side of the set screw will show wear before the right side of the set screw.The expected wear pattern would be a significantly longer streak of wear on one side of the set screw relative to the other as one side of the set screw drags much more than the contralateral side.Non-normal rod-tulip engagement with set screw: because there exists a gap between the rod and tulip, the rod is able to have micromotions causing the set screw to begin backing out.Eventually, the set screw will become unthreaded until there exists only a partial thread engagement.At this point, the tulip thread can be sheared or peeled up due to extreme loading under insufficient thread engagement.Once the thread shears, the set screw can become completely disassociated form the tulip.The implants were used for treatment, not diagnosis.

• Brand Name: INVICTUS
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vide roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC; 1950 camino vide roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vide roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 16632126
• MDR Text Key: 312193932
• Report Number: 2027467-2023-00025
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00190376223582
• UDI-Public: (01)00190376223582(10)AP00436;(01)00190376137902(10)AP00820
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

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
• Device Operator: Health Professional
• Device Model Number: 15054-065-040;15100
• Device Catalogue Number: 15054-065-040;15100
• Device Lot Number: AP00436;AP00820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: No
• 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