MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-17 for VERTEX RECONSTRUCTION SYSTEM G7755124 manufactured by Warsaw Orthopedics.
[183888995]
This part is not approved for use in the united states; however a like device catalog #? 7755124, 510k #? K082728, udi#? (b)(4) was cleared in the united states. Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183888996]
It was reported that the patient underwent fixation at o-c5. Pedicle screw were placed at c2,3,4,5 and the occipital plate was placed due to c1 rupture. Post-op, the adjustable rods were broken at the hinge parts of both sides after operation. Hence on an (b)(6) 2020, a revision surgery was performed. In the revision surgery, the reported rods were replaced with two prebend rods of g7755271. There were no other patient complications as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00323 |
| MDR Report Key | 9845995 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2018-04-17 |
| Date Added to Maude | 2020-03-17 |
| 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 | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | WARSAW ORTHOPEDICS |
| Manufacturer Street | 2500 SILVEUS CROSSING |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERTEX RECONSTRUCTION SYSTEM |
| Product Code | KWP |
| Date Received | 2020-03-17 |
| Model Number | NA |
| Catalog Number | G7755124 |
| Lot Number | 0647684W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WARSAW ORTHOPEDICS |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |