MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-11-24 for JAZZ LOCK 150700 350700 manufactured by Implanet.
[92858633]
First surgery in (b)(6) 2016 for c1-c2 luxation: 2 jazz lock implanted. Revision surgery due to recurrence luxation in (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007675554-2017-00003 |
| MDR Report Key | 7057739 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-11-24 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-11-03 |
| Date Mfgr Received | 2017-11-13 |
| Device Manufacturer Date | 2016-02-28 |
| Date Added to Maude | 2017-11-24 |
| 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 | MR. REGIS LE COUEDIC |
| Manufacturer Street | TECHNOPOLE BORDEAUX MONTESQUIE ALLEE FRANCOIS MAGENDIE |
| Manufacturer City | MARTILLAC, 33650 |
| Manufacturer Country | FR |
| Manufacturer Postal | 33650 |
| Manufacturer G1 | IMPLANET |
| Manufacturer Street | TECHNOPOLE BORDEAUX MONTESQUIE ALLEE FRANCOIS MAGENDIE |
| Manufacturer City | MARTILLAC, 33650, FR |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAZZ LOCK |
| Generic Name | JAZZ LOCK |
| Product Code | OWI |
| Date Received | 2017-11-24 |
| Returned To Mfg | 2017-11-13 |
| Model Number | 150700 |
| Catalog Number | 350700 |
| Lot Number | GGYK-GGXL |
| Device Expiration Date | 2017-02-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 16 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANET |
| Manufacturer Address | TECHNOPOLE BORDEAUX MONTESQUIE ALLEE FRANCOIS MAGENDIE MARTILLAC, 33650, FR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-24 |