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 2019-04-19 for TRANSLACE SPINAL TETHERING SYSTEM 8205300 manufactured by Medtronic Sofamor Danek Usa, Inc.
[142470755]
Product code: owi: bone fixation cerclage, sublaminar. 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
[142470756]
It was reported that the patient underwent posterior lumbar fusion and fixation at t6-l3 due to kyphosis. After approximately one week post-op, patient had fever. When evaluation was performed, infection was found. Hence, a revision surgery was performed for the removal of all implants on (b)(6) 2019. During the revision surgery, it was found that the connectors were very tight and it was difficult to remove the connectors. The removal was carried out by grasping the rod with a rod gripper. No tensioner was used. The severity of the infection was determined to be not serious. Allegedly, the patient has still not recovered. The relatedness of the infection with the implants or surgical procedure could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2019-00442 |
| MDR Report Key | 8531075 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-19 |
| Date of Report | 2019-04-19 |
| Date Mfgr Received | 2019-03-20 |
| Device Manufacturer Date | 2018-01-25 |
| Date Added to Maude | 2019-04-19 |
| 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 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSLACE SPINAL TETHERING SYSTEM |
| Product Code | OWI |
| Date Received | 2019-04-19 |
| Model Number | NA |
| Catalog Number | 8205300 |
| Lot Number | CT17F019 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-19 |