MAUDE Adverse Event Report: LIFE SPINE INC. SOLSTICE; TAP

Model Number	2014-0009
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the reported event, it is likely that the cause of the failure mode was an excessive torsional load placed on the device which exceeded the mechanical strength of the drill/tap.This load was likely contributed to by dense patient bone and/or the application of the load at an off-axis angel from the embedded portion of the tap.Complainant reported no patient impact, however, it is reasonable to assume medical or surgical intervention was required to remove the fractured components from the body cavity.Therefore, this mdr is being submitted out of an abundance of caution.
Event or Problem Description
It was stated that, "in the case yesterday, [the doctor] had the tap snap while tapping left c2.".

• Brand Name: SOLSTICE
• Common Device Name: TAP
• Manufacturer (Section D): LIFE SPINE INC.; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 22382417
• Report Number: 3004499989-2025-00015
• Device Sequence Number: 9355070
• Product Code: KWP
• UDI-Device Identifier: 00190837040215
• UDI-Public: (01)00190837040215(10)CNW24111
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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: 2014-0009
• Device Lot Number: CNW24111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female