MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-18 for CD HORIZON SPINAL SYSTEM 5540030 manufactured by Mdt Sofamor Danek Puerto Rico Mfg.
[183937791]
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
[183937792]
It was reported that the patient underwent tightening of set screws and broken off per usual specifications at ilium due to neuromuscular scoliosis. Post-op, the set screw had come loose from the ballast screws. There were no patient complications as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[188149499]
Radiographic image review result: post of x-ray for lumbar/pelvic fixation provided. Unclear levels instrumented above this. Fusion status is unknown. Both of the iliac set screws were out of the screw heads. Unable to evaluate rod contour or deformity correction on provided images. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2020-00327 |
| MDR Report Key | 9846115 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-02-21 |
| 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 | MDT SOFAMOR DANEK PUERTO RICO MFG |
| Manufacturer Street | BARRIO MARIANNA RD 909, KM0.4 |
| Manufacturer City | HUMACAO PR 00792 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00792 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CD HORIZON SPINAL SYSTEM |
| Generic Name | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
| Product Code | KWP |
| Date Received | 2020-03-18 |
| Model Number | NA |
| Catalog Number | 5540030 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT SOFAMOR DANEK PUERTO RICO MFG |
| Manufacturer Address | BARRIO MARIANNA RD 909, KM0.4 HUMACAO PR 00792 US 00792 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |