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 2019-01-07 for ATLAS CABLE SYSTEM 826-213 manufactured by Warsaw Orthopedics.
[132358062]
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
[132358063]
Pre-operative diagnosis: neck 3-4,4-5 intervertebral disc prolapse procedure: posterior cervical laminectomy and cable fixation it was reported that intra-op, product was broken. Patient achieved solid fusion. The product came in contact with the patient. No fragment remains in the patient. No patient symptoms or complication were reported as result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2019-00014 |
| MDR Report Key | 8224486 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-07 |
| Date of Report | 2019-05-16 |
| Date of Event | 2018-12-14 |
| Date Mfgr Received | 2019-04-19 |
| Device Manufacturer Date | 2016-06-29 |
| Date Added to Maude | 2019-01-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-01-07 |
| Returned To Mfg | 2019-04-17 |
| Model Number | NA |
| Catalog Number | 826-213 |
| Lot Number | 0496001W |
| 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 | 2019-01-07 |