MAUDE Adverse Event Report: LDR MÉDICAL LDR GENERALE INSTRUMENTATION; DISTRACTION FORCEPS

Model Number N/A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

Instrument was received at ldr medical.The review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Product analyse by r and d product manager, as reported patient disc was really collapsed and the space was very thin.Cause of breakage is related to an excessive effort which lead to deformation and breakage of instrument.No impact for the patient, the surgeon managed to apply distraction with another instrument and the implant was inserted without problem.

Event Description

Roi-a : broken distraction forceps.The disc was really collapsed and the space was very thin, the surgeon attempted to introduce the distraction forceps and to apply distraction but a small part of the forceps broke.No impact for the patient, the surgeon managed to apply distraction with another instrument and the implant was inserted without problem.

• Brand Name: LDR GENERALE INSTRUMENTATION
• Type of Device: DISTRACTION FORCEPS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: florence chapaud ; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300 ; 3310648075
• MDR Report Key: 6787423
• MDR Text Key: 82949219
• Report Number: 3004788213-2017-00041
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2017

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IG021R
• Device Lot Number: 510241501/05
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2017
• Initial Date FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR