MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-05-15 for ATLAS CABLE SYSTEM UNK NA manufactured by Warsaw Orthopedic, Inc.
[4384291]
It was reported that the patient underwent spinal fixation using a cable tension system for cervical nerve compression. Sometime post-op, the patient developed muscle tension at cervical implantation site, with distending pain and sense of heaviness, causing difficulty in walking and preventing erect posture. The patient underwent a ct and mri 33 months post-op. It was reported that "the doctor said there were no abnormalities to the surgery. There was no more compression after implantation. "
Patient Sequence No: 1, Text Type: D, B5
[11891496]
(b)(6). (b)(4). Neither the device nor medical records or imaging films were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If additional information is received, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2014-02519 |
| MDR Report Key | 3811415 |
| Report Source | 04 |
| Date Received | 2014-05-15 |
| Date of Report | 2014-04-14 |
| Date Mfgr Received | 2014-04-14 |
| Date Added to Maude | 2014-05-15 |
| 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 |
| Reporter Occupation | OTHER CAREGIVERS |
| 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 | 2014-05-15 |
| Model Number | UNK |
| Catalog Number | NA |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2014-05-15 |