MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-09 for ATLANTIS TRANSLATIONAL SPINAL SYSTEM UNK manufactured by Medtronic Sofamor Danek Usa, Inc..
[187374833]
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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187374834]
Procedure performed: anterior cervical discectomy and fusion. Levels implanted: c7-t1 post-op, the implanted plate cracked. Beginning on or about (b)(6) 2014, plaintiff experienced trouble sleeping due to pain in her neck. Over the next several months, plaintiff continued to report a constant dull, but increasingly achy, pain with intermittent numbness in her fingers. On (b)(6) 2018, plaintiff? S condition worsened, and she visited the hospital. On around (b)(6) 2019, x-rays of plaintiff? S neck where the plate was implanted showed it was cracked, and plaintiff suffered mature arthrodesis that is,artificial induction of joint ossification between two bones by surgery, with segmented cervical fusion; anterolisthesis ( anterolisthesis is a spine condition in which the upper vertebral body slips forward onto the vertebra below; it is another term for spondylolisthesis) at c7-t1 and 2 mm slippage. Plaintiff suffered severe chronic cervical pain and cervical stenosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00293 |
| MDR Report Key | 9804269 |
| Report Source | CONSUMER |
| Date Received | 2020-03-09 |
| Date of Report | 2020-04-02 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-09 |
| 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 | MEDTRONIC SOFAMOR DANEK USA, INC. |
| 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 | ATLANTIS TRANSLATIONAL SPINAL SYSTEM |
| Generic Name | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
| Product Code | KWQ |
| Date Received | 2020-03-09 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC. |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2020-03-09 |