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 2014-07-21 for ATLAS CABLE SYSTEM 826-211 manufactured by Warsaw Orthopedics.
[4600083]
It was reported that a patient underwent scoliosis operation. During the operation, doctor found the cable had broken. The doctor explanted the cable and implanted a new one with no further complications. There were no patient complications.
Patient Sequence No: 1, Text Type: D, B5
[12156420]
(b)(4): the device was not returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[12210724]
Additional information: the two cables were returned in six pieces. All of the cuts except one appear to have been made by a cutting tool like surgical pliers during the removal of the cable. These cuts are straight and completely through the cable with no sign of stress overload. The cut that appears to be the actual failure so that part of the cable appears to have been cut from rubbing against another object then the remaining cable was overloaded. The overload area is noted by the frayed individual strands and the unequal lengths of the cable strands. This appears to be a multimode failure. The initial brake appears to be from the cutting of the cable followed by overload.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2014-03262 |
| MDR Report Key | 3946986 |
| Report Source | 01,05,07 |
| Date Received | 2014-07-21 |
| Date of Report | 2014-06-23 |
| Date of Event | 2014-06-04 |
| Date Mfgr Received | 2014-10-07 |
| Device Manufacturer Date | 2013-08-21 |
| Date Added to Maude | 2014-07-24 |
| 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 | 2014-07-21 |
| Returned To Mfg | 2014-07-22 |
| Model Number | NA |
| Catalog Number | 826-211 |
| Lot Number | 0279191W |
| 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 | 2014-07-21 |