MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-06-24 for ATLAS? CABLE SYSTEM 826-211 manufactured by Warsaw Orthopedic, Inc..
[3517932]
It was reported that a patient underwent an unknown procedure. At an unknown time post-op it was noted that the leader on the cable broke. No further details are known at this time.
Patient Sequence No: 1, Text Type: D, B5
[10750580]
(b)(6). (b)(4). 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.
Patient Sequence No: 1, Text Type: N, H10
[20903381]
Analysis of the returned device confirms that the leader fragmented from the cable. Optical inspection did not identify witness marks or plastic deformation along the length of the cable. The location of the fracture is located at the welded joint. Weld diameter found to be conforming to print specification. The morphology of the fracture is consistent with tensile overload. The above observations are consistent with overload.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2013-02472 |
| MDR Report Key | 3185984 |
| Report Source | 05,07 |
| Date Received | 2013-06-24 |
| Date of Report | 2013-07-15 |
| Date of Event | 2013-06-14 |
| Date Mfgr Received | 2013-07-15 |
| Date Added to Maude | 2013-08-26 |
| 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 | 2013-06-24 |
| Returned To Mfg | 2013-06-26 |
| Catalog Number | 826-211 |
| Lot Number | UNK |
| 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 ORTHOPEDIC, INC. |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-24 |