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 2020-03-18 for ATLAS CABLE SYSTEM 826-211 manufactured by Warsaw Orthopedics.
[183957364]
Product analysis: visual review confirms cable breakage. Microscopic examination of the cable identified material deformation noted just below the location of fracture; the less damaged individual cable strand fracture surfaces reveal a fairly flat appearance and fracture plane angulation consistent with shear overload. This is consistent with shear overload. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183957365]
It was reported that the patient presented with l3-iliac "ads"; and underwent fixation at l3-l4-l5-s1 using transforaminal lumbar interbody fusion. Intra-op, during wiring at l3, the wire disconnected. The surgeon passed the cable through the bone, placed the rod. After performing correction, the surgeon finished applying tension to the reported product and swaging with a cable crimper, but the cable disconnected. The tensioner was laid before swaging, and then swaging was performed. It was said that the tension itself should have been within 30 pounds. No fragment of the cable is remaining in the patient. There were no patient complications as a result of the alleged event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00330 |
| MDR Report Key | 9849556 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2019-09-09 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2015-07-09 |
| Date Added to Maude | 2020-03-18 |
| 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 | 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 | WIRE, SURGICAL |
| Product Code | LRN |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-02-05 |
| Model Number | NA |
| Catalog Number | 826-211 |
| Lot Number | 0398419W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-18 |