MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-06-12 for JAZZ SYSTEMS 150712 350712 manufactured by Implanet.
[77299543]
Clinical expertise by surgeon: a (b)(6) patient: initial intervention: correction by thoraco lumbar instrumentation with pedicle screwing. Limit of upper end in middle thoracic by 2 jazz claw hooks, no protection of upper thoracic spine. Disassembly of the 2 jazz claw took place with probable removal of the hooks placed in first intention. The assumptions made are as follows: primary cause: fracture of the last screwed vertebra and the supra vertebra causing a local kyphosis, and consequently the pull out of the jazz claw. Secondary cause: the jazz claw positioned in the middle thoracic are not used in their maximum configuration (strong mechanical constraints on a kyphosed and stiff spine) secondary cause: stopping the instrumentation in the middle thoracic involves the risk of fracture on osteoporotic spine above the most rigid instrumentation (here pedicular screw) conclusions : this type of instrumentation (jazz claw) does not seem to be the dislodging cause. It seems that the upper level of the instrumentation in middle thoracic spine with hard mechanical constraints, osteoporotic and poor bone quality are the causes. It would have been better to fix the instrumentation on the upper thoracic spine. This was performed during the second surgery. This was the best solution and could have been performed on the first intention with jazz claw with less constraints on the bones. Device discarded.
Patient Sequence No: 1, Text Type: N, H10
[77299544]
Implantable hardware dislodged in situ due to patient pathology progression. Products removed during revision surgery 4 weeks post surgery. Alternative implantable used to replace.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007675554-2017-00002 |
| MDR Report Key | 6633200 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-06-12 |
| Date of Report | 2017-05-16 |
| Date of Event | 2017-03-19 |
| Date Facility Aware | 2017-05-16 |
| Report Date | 2017-05-19 |
| Date Reported to FDA | 2017-05-19 |
| Date Reported to Mfgr | 2017-05-16 |
| Date Mfgr Received | 2017-05-16 |
| Device Manufacturer Date | 2016-06-22 |
| Date Added to Maude | 2017-06-12 |
| 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 | TECHNOPOLE BORDEAUX MONTESQUIE ALLEE FRANCOIS MAGENDIE |
| Manufacturer City | MARTILLAC, 33650 |
| Manufacturer Country | FR |
| Manufacturer Postal | 33650 |
| Manufacturer Phone | 3557995555 |
| 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 SYSTEMS |
| Generic Name | JAZZ CLAW HOOK |
| Product Code | OWI |
| Date Received | 2017-06-12 |
| Model Number | 150712 |
| Catalog Number | 350712 |
| Lot Number | GNXF-FSTUR |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 11 MO |
| 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 | 2017-06-12 |