MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-27 for CAVUX CERVICAL CAGE-SB PD-31-202 manufactured by Providence Medical Technology, Inc..
[176784446]
Female patient underwent successful circumferential fusion on (b)(6) 2020 with interbody devices placed anteriorly and cervical cages placed posteriorly at c5-c6 and c6-c7. 3 days post procedure, patient complained of shoulder and tricep pain initiating a ct scan. The ct scan confirmed one of four cervical cages placed posteriorly, at c6-c7 on the right, was malpositioned and could be contributing to nerve root irritation and pain. On (b)(6) 2020, the surgeon removed the cage and performed a foraminotomy at c6-c7 on the right. No device defect or malfunction or permanent impairment was reported by the surgeon and no issues were reported at any other treated level. The surgeon hypothesized that shallow facets and anterior distraction could have contributed to cage malposition. The patient is healing as expected with no subsequent issues.
Patient Sequence No: 1, Text Type: N, H10
[176784447]
Female patient underwent successful circumferential fusion on (b)(6) 2020 with interbody devices placed anteriorly and cervical cages placed posteriorly at c5-c6 and c6-c7. 3 days post procedure, patient complained of shoulder and tricep pain initiating a ct scan. The ct scan confirmed one of four cervical cages posteriorly, at c6-c7 on the right, was malpositioned and could be contributing to nerve root irritation and pain. On (b)(6) 2020, the surgeon removed the cage and performed a foraminotomy at c6-c7 on the right. No device defect or malfunction or permanent impairment was reported by the surgeon. The surgeon hypothesized that shallow facets and anterior distraction could have contributed to cage malposition. The patient is healing as expected with no subsequent issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009394448-2020-00001 |
| MDR Report Key | 9635213 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-21 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2020-01-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. JANIE MANDRUSOV |
| Manufacturer Street | 3875 HOPYARD RD SUITE 300 |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 4153013128 |
| Manufacturer G1 | PROVIDENCE MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 3875 HOPYARD RD SUITE 300 |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAVUX CERVICAL CAGE-SB |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL |
| Product Code | ODP |
| Date Received | 2020-01-27 |
| Model Number | PD-31-202 |
| Catalog Number | PD-31-202 |
| Lot Number | 047729 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROVIDENCE MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 3875 HOPYARD RD SUITE 300 PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-27 |