MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-03-18 for ATLAS CABLE SYSTEM 826-211 manufactured by Warsaw Orthopedics.
[4259933]
It was reported that the patient presented to surgery with atlantoaxial dislocation. The patient underwent a procedure for cervical fusion with cable fixation. During a routine follow-up, it was found that left cable was broken. Patient was asymptomatic. The patient underwent a revision surgery where the cable were removed from both sides and replaced.
Patient Sequence No: 1, Text Type: D, B5
[11550459]
(b)(4). Neither device nor applicable imaging studies were returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2014-01885 |
| MDR Report Key | 3684750 |
| Report Source | 01,05,07 |
| Date Received | 2014-03-18 |
| Date of Report | 2014-02-16 |
| Date of Event | 2014-02-16 |
| Date Mfgr Received | 2014-02-16 |
| Date Added to Maude | 2014-03-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HUZEFA MAMOOLA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| 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 | 2014-03-18 |
| Model Number | NA |
| Catalog Number | 826-211 |
| Lot Number | UNKNOWN |
| 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 | 2014-03-18 |