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

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 03/17/2022

Event Type  Injury  

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.

Event Description

On (b)(6) 2022, it was reported a rod backed out of the construct after a single level alif (l5-si) with posterior screws.

Manufacturer Narrative

A3.Male.D4.Model #: 15295-55-050; 15025-065-045; 15025-065-045; 15100; 15100.Catalog # 15295-55-050; 15025-065-045; 15025-065-045; 15100; 15100.Lot # ct51196; 8639510; 8851103; ap00011; ap00399.Udi: (b)(4).D9.Yes.E1: (b)(6).H3.Yes.H6: health impact 4629.Component code: 4721; 568.Investigation findings: 3207.Type of investigation: 10; 3331.Investigation conclusion: 22.H10: a review of the device history records did not identify any manufacturing or processing-related irregularities related to the implant components.Device evaluation: pn 15100 set screws - note non-normalized rod contact as depicted by a single indentation on the distal set screw face towards the outermost edge.The surface contacting the rod also does not extend in towards the center of the set screw indicating reducer rod to set screw surface area contact.Pn 15295-55-50 mis rod - surface contacting markings demonstrate contact on one side of the set screw indicating non-normalization between the rod and set screws.Typical surface contact patterns would consist of two markings for each set screw contact to depict the set screw has normalized to the rod in two contact locations.Pn 15025-065-045 - rod seating surface depicts rod contact on just one side of the screw rod seating surface, indicating non-normalization of the rod.Failure mode and root cause: construct failure due to non-normalization of the rod to screws and set screws interface, this is more common in mis applications where direct visibility and imaging of rod to screw is minimized/compromised.Markings depict that proper lockdown was achieved but the rod was not fully normalized to the screws and set screws, creating a construct with diminished gripping capacity resulting in a possibility of rod slippage.Normalization of the rod is further complicated when fixating and spanning segments with increased lordosis where the polyaxial range of cranial-caudal motion of the screw may limit the ability to fully normalize to the rod as in l5-s1."labeling review: 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 components.".

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• 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: 14131810
• MDR Text Key: 289444193
• Report Number: 2027467-2022-00022
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213460
• 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: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2022
• 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