MAUDE Adverse Event Report: LIFE SPINE GRUVE; DRIVER

Catalog Number	150-266
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is hypothesided that the root cause of the reported event was likely insufficient wall thickness of the head lock sleeve.This issue may have contributed to by repeated user of over-tightening of the head lock sleeve onto the screw, which could have placed additional stress on the wall, leading to the failure.
Event or Problem Description
It was stated that "the retaining screw driver broke during the operation today.There was no excessive force or angulation on the driver.As the dr.Was inserting the screw a piece broke off.".

• Brand Name: GRUVE
• Common Device Name: DRIVER
• 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: 24563901
• Report Number: 3004499989-2026-00011
• Device Sequence Number: 18508300
• Product Code: KWQ
• UDI-Device Identifier: 00190837060848
• UDI-Public: (01)00190837060848(10)CNW24081
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130202
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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 Catalogue Number: 150-266
• Device Lot Number: CNW24081
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 03/10/2026
• 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
• Patient Age: 52 YR
• Patient Sex: Unknown