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

Model Number UNKNOWN

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 11/02/2023

Event Type  Injury  

Manufacturer Narrative

The explanted hardware was not returned for evaluation.The identifying part/lot numbers were not provided.Neither photographs nor radiograph images were available for review.Alphatec has requested additional information regarding this report.Based on current information provided, a root cause could not be determined.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.1.Initial or delayed loosening, disassembly, bending, dislocation and/or breakage of device components.Postoperative management: the implants are designed and intended as temporary fixation devices.The devices should be removed after complete healing has occurred.Devices which are not removed after serving their intended purpose may bend, dislocate, or break and/or cause corrosion, localized tissue reaction, pain, infection, and/or bone loss due to stress shielding.Complete postoperative management to maintain the desired result should also follow implant removal surgery.

Event Description

A patient underwent a posterior lumber interbody fusion procedure on an unknown date.Around two years postoperatively, the patient reported some pain.Radiograph images revealed a solid fusion; however, the l5 screw on the left appeared to be a little medial.Revision surgery was performed, and all previously implanted hardware was removed.

• Brand Name: ARSENAL
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): 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: 18248068
• MDR Text Key: 329500434
• Report Number: 2027467-2023-00081
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152968
• 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
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2023
• 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): Required Intervention