MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-04-26 for FB CW SCREW D4.5MM L30MM N/A FS4530T manufactured by Ldr M?dical.
[106582295]
Without a product return, no product evaluation can be conducted. No information were received about the patient state of health. 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. As reported the event consist on bad trajectory and not related to a device issue. The investigation found no evidence to indicate a device issue. As indicated in facetbridge surgical technique : "fluoroscopy is necessary to guide and to ensure correct positioning of the implant. Sagittal and frontal x-rays of the spine allow to determine facets morphology and geometry". "a x-rays must be taken to confirm trajectory and length of the screw to insert", steps of trajectory preparation are described at step 1 of surgical technique. Root cause of incorrect implant position is related to an user error. Device not returned as discarded.
Patient Sequence No: 1, Text Type: N, H10
[106582296]
During facetbridge surgery, the first screw took a bad trajectory, the surgeon tried to replace it but without success. So he removed it and left the second screw, well placed, in place. The surgeon placed a percutaneous osteosynthesis system (2 pedicle screws + 1 rod) to replace the removed facet screw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004788213-2018-00125 |
| MDR Report Key | 7463610 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-04-26 |
| Date of Report | 2018-04-26 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2018-03-29 |
| Device Manufacturer Date | 2016-08-23 |
| Date Added to Maude | 2018-04-26 |
| 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. |
| 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 | FB CW SCREW D4.5MM L30MM |
| Generic Name | SYSTEM, FACET SCREW SPINAL DEVICE |
| Product Code | MRW |
| Date Received | 2018-04-26 |
| Model Number | N/A |
| Catalog Number | FS4530T |
| Lot Number | 679682 |
| ID Number | (01)03662663022958(17)210701(1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-04-26 |