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 2020-03-28 for CD HORIZON SOLERA SPINAL SYSTEM 6540530 manufactured by Mdt Sofamor Danek Puerto Rico Mfg.
[186572590]
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
[186572591]
Pre op diagnosis: loose set screws procedure performed: revision surgery to replace loose set screws post-op, set screws back out. Initial post op x-ray looked intact but follow up x-ray set screw on right l5 screw noted to be not sitting in screw head. Revision surgery undertaken to replace set screw. The patient suffered pain as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00386 |
| MDR Report Key | 9892534 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-28 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-28 |
| 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 SOLERA SPINAL SYSTEM |
| Generic Name | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE |
| Product Code | NKB |
| Date Received | 2020-03-28 |
| Model Number | NA |
| Catalog Number | 6540530 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Other | 2020-03-28 |