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 2018-09-04 for ATLAS CABLE SYSTEM 826-213 manufactured by Warsaw Orthopedics.
[119026991]
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
[119026992]
Pre-op diagnosis: axial dislocation with incomplete spinal nerve injury, posterior arch nonunion, lumbar 5/ sacral 1 disc herniation procedure: open reduction of axial dislocation via posterior approach, decompression of spinal canal and cantilever beam internal fixation it was reported that intra-op, a single cable with integral crimp broke during the procedure. The product came in contact with the patient. There are no known complications to the patient in the reported event.
Patient Sequence No: 1, Text Type: D, B5
[125501742]
Product analysis: the cable was returned with a fracture at the weld junction. A microscopic review of the fracture face reveals a ductile failure with a concaved surface consistent with necking near the failure point. This is consistent with a tensile overload on the axis of the cable. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2018-01200 |
| MDR Report Key | 7841130 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-04 |
| Date of Report | 2018-10-23 |
| Date of Event | 2018-08-10 |
| Date Mfgr Received | 2018-10-22 |
| Device Manufacturer Date | 2018-03-19 |
| Date Added to Maude | 2018-09-04 |
| 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 | ATLAS CABLE SYSTEM |
| Generic Name | CABLE |
| Product Code | ISN |
| Date Received | 2018-09-04 |
| Returned To Mfg | 2018-10-10 |
| Model Number | NA |
| Catalog Number | 826-213 |
| Lot Number | 0640587W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-09-04 |