MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2015-06-18 for ATLAS CABLE SYSTEM 826-211 manufactured by Warsaw Orthopedics.
[22896955]
(b)(6). (b)(4). The device was returned to the manufacturer. Evaluation is in progress.
Patient Sequence No: 1, Text Type: N, H10
[22896956]
It was reported that the patient underwent a procedure to treat spinal deformity. During placement of a cable implant around t3 lamina, the cable frayed at the end and a large piece of metal came off. The surgeon cut off the portion of the cable that was not used. The remaining portion left implanted was intact. No patient complications were associated with the event.
Patient Sequence No: 1, Text Type: D, B5
[25518855]
Product analysis :visual review confirms cable breakage, with approximately 90 mm of cable missing from this side of the cable. Microscopic examination of the cable identifies bend in the cable with strand damage both above and below the breakage. The angle and location of strand breakage is consistent with the cable coming in contact with a sharp corner during tensile loading. Microscopic examination of the individual cable strand fracture surfaces reveal fairly flat fracture surfaces, with a surface angulation consistent with shear overload. Fracture surfaces containing varying degrees of damage and mechanical smearing. The above observations are consistent with shear overload.
Patient Sequence No: 1, Text Type: N, H10
[100600260]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2015-01225 |
| MDR Report Key | 4854382 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-06-18 |
| Date of Report | 2015-08-24 |
| Date of Event | 2015-05-19 |
| Date Mfgr Received | 2015-08-24 |
| Date Added to Maude | 2015-07-15 |
| 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 | GREG ANGLIN |
| 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 | 2015-06-18 |
| Returned To Mfg | 2015-05-22 |
| Model Number | NA |
| Catalog Number | 826-211 |
| Lot Number | UNKNOWN |
| 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 | 2015-06-18 |