MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-03-06 for INTERVENTIONAL SPINE 9024-01 manufactured by Interventional Spine, Inc..
[101587837]
Product complaint # (b)(4). A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[101587838]
It was reported, revision surgery for the interventional spine facet screw (product code/description below) occurred on friday (b)(6) 2018. Revision surgery went well with a depuy spine revision set. No further information known. Part number for ispine screw 9024-01 (unrecognized part in unity) reason for revision is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2018-50204 |
| MDR Report Key | 7316144 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-03-06 |
| Date of Report | 2018-02-14 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-02-14 |
| Date Added to Maude | 2018-03-06 |
| 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 | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| Manufacturer G1 | INTERVENTIONAL SPINE, INC. |
| Manufacturer Street | 13700 ALTON PKWY. SUITE 160 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERVENTIONAL SPINE |
| Generic Name | SYSTEM, FACET SCREW SPINAL DEVICE |
| Product Code | MRW |
| Date Received | 2018-03-06 |
| Catalog Number | 9024-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVENTIONAL SPINE, INC. |
| Manufacturer Address | 13700 ALTON PKWY. SUITE 160 IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-06 |