MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-02-28 for BONE-LOK MVP SCREW SMCD-45-6070S manufactured by Interventional Spine, Inc..
[15501601]
Implant placed in position. Compression device would not advance collar as is customary. Repeated attempt to advance collar to no avail. Compression pin removed with compression pin removal tool. Attempted to remove implant with driver. Driver would not fit in device. Finally, removed device with needle nose pliers.
Patient Sequence No: 1, Text Type: D, B5
[15647929]
Root cause: the implant is compressed after insertion into the bone. The device was compressed (collar advanced) before insertion, which prevents compression tool to advance any further, and prevents driver from mating with screw. Initially, it was determined the event was not reportable. On a subsequent re-review, it was determined this event should have been reported. Device eval: returned device was visually inspected. The implant was fully compressed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2011-00040 |
| MDR Report Key | 2045610 |
| Report Source | 07 |
| Date Received | 2011-02-28 |
| Date of Report | 2003-07-28 |
| Date of Event | 2003-07-28 |
| Date Mfgr Received | 2003-07-28 |
| Device Manufacturer Date | 2002-08-01 |
| Date Added to Maude | 2012-02-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 13700 ALTON PKWY. STE. 160 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494720006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE-LOK MVP SCREW |
| Product Code | MRW |
| Date Received | 2011-02-28 |
| Returned To Mfg | 2003-07-29 |
| Model Number | SMCD-45-6070S |
| Catalog Number | SMCD-45-6070S |
| Lot Number | R081502H |
| Device Expiration Date | 2004-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVENTIONAL SPINE, INC. |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-02-28 |