MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS; POSTERIOR CERVICAL SCREW SYSTEM

Model Number 18500-56; 18501; 18100

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.

Event Description

Set screw and tulip have become displaced.Revision surgery will be required.Revision surgery date is to be determined.

Manufacturer Narrative

A revision surgery was conducted on (b)(6) 2021.Both ti oc prebent rods (pn 18240-40) used in the case, as well as the set screws (pn 18100), and 1 occipital tulips (pn 18501) were returned to atec.The explanted implants were evaluated by engineering.The investigation concluded the construct may not have achieved proper lock down.To achieve proper lock down of the plate construct, the rod needs to contact the superior and inferior aspect of the plate wing.Based on assessment of the wear marks on the rod, the construct may not have achieved proper lock down.It appears that the rod was locked down on the superior aspect of the occipital plate wing, but not the inferior aspect of the occipital plate wing.The plate (pn 18500-56) was not returned and therefore, couldn't not be evaluated as part of this investigation.The portion on the two rods (pn 18240-40) which contains the lot numbers were cut off and not returned.Review of manufacturing records could not be completed.Qty 7 of pn 18100 were returned and the following lns were confirmed: ln 8722402 x1 , ln 8836501 x1, ln, 8722401 x 1, ln 8567102 x1, ln 8567203 x1, ln 8567201 x 2.Review of the manufacturing records indicate all set screws met specifications prior to being released into the field.Qty 1 of pn 18501 ln 8728903 was also returned.Review of the manufacturing records indicate the implant met specifications prior to being released into the field.Review of lit-85041 states the following: "step 11: final tightening: final tighten set screws over seated rods using the final tightening driver with torque handle through the occipital counter torque.Caution: failure to tighten the set screws using the recommended instrument(s) could compromise the mechanical stability of the construct." labeling review: "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.Initial or delayed loosening, disassembly, bending, dislocation and/or breakage of device components.".

• Brand Name: INVICTUS
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 12021266
• MDR Text Key: 257141009
• Report Number: 2027467-2021-00039
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• PMA/PMN Number: K203125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18500-56; 18501; 18100
• Device Catalogue Number: 18500-56; 18501; 18100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization