MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-03 for INTERBRIDGE IMPLANT HOLDER N/A IB9028R manufactured by Ldr M?dical.
[143960759]
This medwatch is submitted to send the initial report of this complaint. Additional information was requested to better understand the event. So far, the lot of the concerned instrument was not communicated by the reporter. Therefore , it's not possible to perform the review of the device history records. Investigation still in progress.
Patient Sequence No: 1, Text Type: N, H10
[143960760]
Interbridge : cannot deploy locking plates. It was reported that a surgeon that is very familiar with interbridge perform a surgery on (b)(6) 2019. The implant was loaded onto the inserter correctly. However the inserter was not deploying the locking plates. When they tried to take it off it wouldn't release from the inserter. Time had gone by and the surgeon asked to have the second inserter which was ready for another case to be opened and a new implant placed. When surgeon put the implant on the second inserter everything was loaded fine. Surgery was therefore completed with another instrument without further complication. The first inserter just didn't seem to be working properly, the surgeon felt that the blue button wasn't quite right but and the plates where not deploying intraoperatively. Therefore , he asked for the second inserter. He reloaded it with the same size of implant and it was fine. It was a delay between 15 and 20 minutes. Additional information was received on april 24th: no issues with the patient as it was implanted successfully with a second implant. No pictures are available. Additional information was requested. Investigation still in progress.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004788213-2019-00140 |
| MDR Report Key | 8577592 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-05-03 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-04-04 |
| Date Mfgr Received | 2019-04-09 |
| Date Added to Maude | 2019-05-03 |
| 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. |
| 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 | INTERBRIDGE IMPLANT HOLDER |
| Generic Name | INTERSPINOUS POSTERIOR FIXATION SYSTEM AND ASSOCIATED INSTRUMENTS |
| Product Code | PEK |
| Date Received | 2019-05-03 |
| Model Number | N/A |
| Catalog Number | IB9028R |
| Lot Number | NO INFORMATION |
| 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 | 2019-05-03 |