MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-11 for LDR GENERALE INSTRUMENTATION N/A IG021R manufactured by Ldr M?dical.
[82949219]
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.
Patient Sequence No: 1, Text Type: N, H10
[82949220]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004788213-2017-00041 |
| MDR Report Key | 6787423 |
| Date Received | 2017-08-11 |
| Date of Report | 2017-08-08 |
| Date of Event | 2017-07-12 |
| Date Mfgr Received | 2017-07-12 |
| Device Manufacturer Date | 2015-12-18 |
| Date Added to Maude | 2017-08-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. FLORENCE CHAPAUD |
| Manufacturer Street | QUARTIER EUROPE DE L 5, RUE DE BERLIN |
| Manufacturer City | SAINTE-SAVINE 10300 |
| Manufacturer Country | FR |
| Manufacturer Postal | 10300 |
| Manufacturer Phone | 3310648075 |
| Manufacturer G1 | LDR M |
| Manufacturer Street | QUARTIER EUROPE DE L 5, RUE DE BERLIN |
| Manufacturer City | SAINTE-SAVINE 10300 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 10300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LDR GENERALE INSTRUMENTATION |
| Generic Name | DISTRACTION FORCEPS |
| Product Code | GEN |
| Date Received | 2017-08-11 |
| Returned To Mfg | 2017-07-17 |
| Model Number | N/A |
| Catalog Number | IG021R |
| Lot Number | 510241501/05 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LDR M?DICAL |
| Manufacturer Address | QUARTIER EUROPE DE L?OUEST 5, RUE DE BERLIN SAINTE-SAVINE 10300 FR 10300 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-11 |