MAUDE Adverse Event Report: LIFE SPINE, INC. LATERAL DISC PREP; DISTRACTOR

Catalog Number	2022-0021
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that, "it snapped in a case on sunday.".
Additional Manufacturer Narrative
Based on the reported event and the returned device, it is hypothesized that the root cause of the failure was insufficient mechanical properties of the device's distal tip to withstand the applied forces.It is likely that while advancing the attached modular tip within the working space, potentially requiring torsional force or rocking, an excessive or off-axis load caused excessive stress on the distal tip, ultimately leading to its fracture.

• Brand Name: LATERAL DISC PREP
• Common Device Name: DISTRACTOR
• Manufacturer (Section D): LIFE SPINE, INC.; 139951 s quality drive; huntley IL 60142
• Manufacturer Contact: bridget kinard ; 13951 s quality drive; huntley, IL 60142 ; 3238062350
• MDR Report Key: 23033219
• Report Number: 3004499989-2025-00023
• Device Sequence Number: 9582071
• Product Code: LXH
• UDI-Device Identifier: 00190837155001
• UDI-Public: (01)00190837155001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111953
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/11/2025

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 Catalogue Number: 2022-0021
• Device Lot Number: CNW22121M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown