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 2020-03-25 for INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM G3603522 manufactured by Mdt Sofamor Danek Puerto Rico Mfg.
[185037104]
Product was not 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
[185037105]
It was reported that the patient presented with fracture-dislocation at c5; and underwent posterior fixation at c5-c6. At the stage of taking x-ray image, after performing fixation at c5-c6 and wound closure, there was a suspicion that the screw on the right side of c6 had deviated towards the direction of va (vertebral artery). So, a ct scan was performed, and it was confirmed that the screw had deviated towards the direction of va. Mri was also performed and there were no va injury or occlusion found. A revision surgery was performed on the same day and the screw was completely explanted. There was no bleeding and wound closure was continued to be performed. Then, herniation at c5-c6 prolapsed after the operation, and laminoplasty was performed in the revision surgery on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00369 |
| MDR Report Key | 9879480 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-25 |
| 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 | MDT SOFAMOR DANEK PUERTO RICO MFG |
| Manufacturer Street | BARRIO MARIANNA RD 909, KM0.4 |
| Manufacturer City | HUMACAO PR 00792 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00792 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM |
| Generic Name | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| Product Code | KWP |
| Date Received | 2020-03-25 |
| Model Number | NA |
| Catalog Number | G3603522 |
| Lot Number | H5560577 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT SOFAMOR DANEK PUERTO RICO MFG |
| Manufacturer Address | BARRIO MARIANNA RD 909, KM0.4 HUMACAO PR 00792 US 00792 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |