MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-02 for DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM G6626747 manufactured by Mdt Sofamor Danek Puerto Rico Mfg.
[178639566]
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
[178639567]
It was reported that intra-op, the implant cracked near screw holes during insertion. The cracked implant was then completely explanted; and was replaced with a new one. No patient complications were reported due to this event.
Patient Sequence No: 1, Text Type: D, B5
[187787617]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187787618]
The patient had a pre-operative diagnosis of degenerative disk disease; and underwent anterior cervical discectomy and fusion (acdf) at c3-c4.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00004 |
| MDR Report Key | 9538630 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-27 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2020-01-02 |
| Device Manufacturer Date | 2019-10-08 |
| Date Added to Maude | 2020-01-02 |
| 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 |
| Product Code | OVE |
| Date Received | 2020-01-02 |
| Model Number | NA |
| Catalog Number | G6626747 |
| Lot Number | H5564369 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-02 |