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 2020-02-18 for DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM G6626526 manufactured by Mdt Sofamor Danek Puerto Rico Mfg.
[179721185]
Product was not 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
[179721186]
It was reported that the patient underwent anterior cervical discectomy and fusion (acdf) surgery with standalone due to cervical disc degenerative disease. Intra-op, cage was broke while implanting. The cage was removed intra--operatively itself. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00174 |
| MDR Report Key | 9719057 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2018-01-08 |
| Date Added to Maude | 2020-02-18 |
| 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 | DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL |
| Product Code | OVE |
| Date Received | 2020-02-18 |
| Model Number | NA |
| Catalog Number | G6626526 |
| Lot Number | H5404326 |
| 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 | 2020-02-18 |