MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-10-03 for FACETBRIDGE N/A FS4535W manufactured by Ldr M?dical.
[88009899]
Without a product return, no product evaluation is able to be conducted. The review of traceability and 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.
Patient Sequence No: 1, Text Type: N, H10
[88009900]
Facetbridge: washer of screw come apart. Washer of screw come apart upon loading on to the screw driver prior to being implanted, it was reset on to the screw head but dislodged once again. A new implant was opened and used without further issue reported. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004788213-2017-00126 |
| MDR Report Key | 6910327 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-10-03 |
| Date of Report | 2018-09-20 |
| Date of Event | 2017-05-01 |
| Date Mfgr Received | 2017-05-02 |
| Device Manufacturer Date | 2016-08-09 |
| Date Added to Maude | 2017-10-03 |
| 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. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. 5, RUE DE BERLIN |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| 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 | 3 |
| Brand Name | FACETBRIDGE |
| Generic Name | SYSTEM, FACET SCREW SPINAL DEVICE |
| Product Code | MRW |
| Date Received | 2017-10-03 |
| Model Number | N/A |
| Catalog Number | FS4535W |
| Lot Number | 673496 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-10-03 |