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

Model Number	47127
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2027467-2023-00026
• Device Sequence Number: 6615984
• Product Code: KWP
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K152968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Male