MAUDE Adverse Event Report: LDR MEDICAL DISTRACTION FORCEPS; FORCEPS, GENERAL & PLASTIC SURGERY

Catalog Number	IG021R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a distraction forceps broke when inserted into the intervertebral space during a double lumbar level procedure.The break occurred at the second level, and resulted in the procedure being aborted and will need to be completed at a later date.
Additional Manufacturer Narrative
H6: additional impact code: 2563.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: investigation type, findings, and conclusions.A review of the dhr was conducted and found no indications of manufacturing issues.An inspection of the part shows the distraction forceps arm has fractured at the connection end.This event likely cannot be attributed to manufacturing or design related issues.The complaint is confirmed for one general instrument distraction forceps for the failure of fracture leading to the procedure being aborted.The failure is believed to be attributed to excessive forces applied during distraction because inspection of the device reveals the fracture occurred when forces were being applied perpendicular to the connection piece.This device is used for treatment.
Event or Problem Description
It was reported that a distraction forceps broke when inserted into the intervertebral space during a double lumbar level procedure.The break occurred at the second level, and resulted in the procedure being aborted and will need to be completed at a later date.

• Brand Name: DISTRACTION FORCEPS
• Common Device Name: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 23730151
• Report Number: 3004788213-2025-00069
• Device Sequence Number: 9722919
• Product Code: GEN
• UDI-Device Identifier: 03662663037662
• UDI-Public: (01)03662663037662(10)59001-01
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: IG021R
• Device Lot Number: 59001-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic