MAUDE Adverse Event Report: LIFE SPINE SOLSTICE; DRILL

Model Number	2014-0009
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was identified that the fracture appears directly through the threds on the subject device.It is likely that the root cause was excessive torsional load expierenced with the tap shaft.This torsional load was likely contributed to bone quality or application of the load at an angles off-axis from the embedded portion of the drill/tap.The patient may have possessed dense bone which increased the tosion force necessary to tap the vertebral body.
Event or Problem Description
It was stated that " drill broke while inserting into the right c2 pedicle, was removed.To my knowledge there were no other issues.".

• Brand Name: SOLSTICE
• Common Device Name: DRILL
• Manufacturer (Section D): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE; 13951 quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 24115755
• Report Number: 3004499989-2026-00004
• Device Sequence Number: 6075786
• Product Code: KWP
• UDI-Device Identifier: 00190837040215
• UDI-Public: (01)00190837040215
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/20/2026
• 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; Hospitalization
• Patient Age: 21 YR
• Patient Sex: Female