MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-07 for JAZZ 350150 manufactured by Implanet.
[67116086]
The review of the batch record did not show any non conformity. The products are conform to implanet specifications.
Patient Sequence No: 1, Text Type: N, H10
[67116087]
Initial surgery : (b)(6) 2015. Patient returned to surgeon two years after the initial surgery, complaining of discomfort. It was determined that screws at s1 had pulled out and that the two most proximal jazz bands implanted had broken. The surgeon extended the construct up two levels to t6 and down a level to the pelvis. It should be noted that the two jazz that broke were implanted at the proximal end of the construct without support of screws.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007675554-2017-00001 |
| MDR Report Key | 6307077 |
| Date Received | 2017-02-07 |
| Date of Report | 2017-02-06 |
| Date Mfgr Received | 2017-01-24 |
| Device Manufacturer Date | 2013-10-28 |
| Date Added to Maude | 2017-02-07 |
| 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. R LE COU |
| Manufacturer Street | ALLEE FRANCOIS MAGENDIE TECHNOPOLE BORDEAUX MONTESQUIE |
| Manufacturer City | MARTILLAC, FRANCE 33650 |
| Manufacturer Country | US |
| Manufacturer Postal | 33650 |
| Manufacturer Phone | 0033357995 |
| Manufacturer G1 | IMPLANET |
| Manufacturer Street | TECHNOPOLE BORDEAUX MONTESQUIE ALLEE FRANCOIS MAGENDIE |
| Manufacturer City | MARTILLAC, 33650, FR |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JAZZ |
| Generic Name | MULTI-PURPOSE SPINE CONNECTOR |
| Product Code | OWI |
| Date Received | 2017-02-07 |
| Catalog Number | 350150 |
| Lot Number | DROZ0016 |
| Device Expiration Date | 2018-10-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-02-07 |