MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-03-20 for FACETFUSE FACET SCREWS IM0006 manufactured by Spinefrontier.
[3319364]
Note: a full audit of all legacy complaints since the inception of the company (2007) was conducted to assure any non-conformities that may exist from earlier years were discovered and properly documented and addressed. During the audit this reportable event was identified and is now being submitted. Previous personnel had deemed this a non-reportable. This event was to be reported within 30 days of occurring. Pt was returned to surgery on (b)(6) 2009, approx 3. 5 months following a two-level facet fixation and interbody fusion, due to an infection. During the procedure, the surgeon removal one interbody and kept all screws in place. Screws were noted as being loose and there was a non-union. Physician did not feel that infection was related to spinefrontier devices. Infection was not proximate to facet joints, but had spread into the disc space. Screws were reset to desired depth/insertion. The system was confirmed to have been sterilized prior to use.
Patient Sequence No: 1, Text Type: D, B5
[10675877]
The system is sold non-sterile and is sterilized at user site following sterilization process outlined in surgical technique and package insert. Product labeling also addresses the risk of non-union and infection. Device history records were reviewed and all quality requirements have been met.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005977257-2013-00007 |
| MDR Report Key | 3019127 |
| Report Source | 07 |
| Date Received | 2013-03-20 |
| Date of Report | 2013-03-13 |
| Date of Event | 2009-08-28 |
| Date Mfgr Received | 2009-08-28 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2013-03-26 |
| 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 Contact | NICOLE BAGINSKI |
| Manufacturer Street | 500 CUMMINGS CENTER SUITE 3500 |
| Manufacturer City | BEVERLY MA 01915 |
| Manufacturer Country | US |
| Manufacturer Postal | 01915 |
| Manufacturer Phone | 9783233990 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FACETFUSE FACET SCREWS |
| Generic Name | FACET SCREWS |
| Product Code | MRW |
| Date Received | 2013-03-20 |
| Model Number | IM0006 |
| Lot Number | 98490 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINEFRONTIER |
| Manufacturer Address | 500 CUMMINGS CENTER SUITE 3500 BEVERLY MA 01915 US 01915 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-20 |