MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-23 for COMPOSITE SCREW LIGAFIX 60 DIAM. 8 - L:25 MM COM6008025 manufactured by S.b.m. Sas.
| Report Number | 3004549189-2020-00003 |
| MDR Report Key | 9864693 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2019-11-06 |
| Date Mfgr Received | 2019-11-08 |
| Device Manufacturer Date | 2013-12-08 |
| Date Added to Maude | 2020-03-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. REGINE BAREILLES |
| Manufacturer Street | ZI DU MONGE |
| Manufacturer City | LOURDES, FRANCE 65100 |
| Manufacturer Country | FR |
| Manufacturer Postal | 65100 |
| Manufacturer G1 | S.B.M. SAS |
| Manufacturer Street | ZI DU MONGE |
| Manufacturer City | LOURDES, FRANCE 65100 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 65100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPOSITE SCREW LIGAFIX 60 DIAM. 8 - L:25 MM |
| Generic Name | INTERFERENCE SCREW |
| Product Code | MAI |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2019-12-02 |
| Catalog Number | COM6008025 |
| Lot Number | 183723 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | S.B.M. SAS |
| Manufacturer Address | ZI DU MONGE LOURDES, FRANCE 65100 FR 65100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-23 |