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

Model Number 47127

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

The implant was used for treatment, not diagnosis.It remains in situ.Radiograph images were not provided to confirm the event.The date of the postoperative visit is unknown.The identifying lot number was not provided; therefore, a review of the device history records could not be conducted.Based on the information provided, a root cause could not be determined.If additional information is provided, a supplemental report will be submitted.Labeling review: "intraoperative management: final set screw tightening: all set screws must be tightened using the appropriate instrument (e.G., torque handle) as indicated in the surgical technique guide.Possible adverse effects: initial or delayed loosening, disassembly, bending, dislocation and/or breakage of device.".

Event Description

During a postoperative visit, the surgeon noticed a set screw had backed out of the tulip head.There are no plans for revision surgery at this time.Original surgery date is unknown.

• Brand Name: ARSENAL SPINAL FIXATION SYSTEM
• 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: 16667435
• MDR Text Key: 312589307
• Report Number: 2027467-2023-00026
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/03/2023

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 Operator: Health Professional
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 04/03/2023
• 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): Other
• Patient Age: 53 YR
• Patient Sex: Male