MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-19 for M3 STAND-ALONE ANTERIOR LUMBAR SYSTEM LK300-1000 manufactured by Corelink Surgical, Llc.
| Report Number | 3006494201-2020-00002 |
| MDR Report Key | 9727969 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2019-11-13 |
| Date Added to Maude | 2020-02-19 |
| 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. ALLISON SCHMIDT |
| Manufacturer Street | 2072 FENTON LOGISTICS PARK |
| Manufacturer City | ST. LOUIS, MO |
| Manufacturer Country | US |
| Manufacturer Phone | 3497808 |
| Manufacturer G1 | CORELINK SURGICAL, LLC |
| Manufacturer Street | 2072 FENTON LOGISTICS PART |
| Manufacturer City | ST. LOUIS, MO |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M3 STAND-ALONE ANTERIOR LUMBAR SYSTEM |
| Generic Name | M3 STAND-ALONE ALIF LOCK ASSEMBLY |
| Product Code | OVD |
| Date Received | 2020-02-19 |
| Returned To Mfg | 2020-01-20 |
| Model Number | LK300-1000 |
| Lot Number | SM108763 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORELINK SURGICAL, LLC |
| Manufacturer Address | 2072 FENTON LOGISTICS PARK ST. LOUIS, MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-19 |