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 SCREWS IM0006 manufactured by Spinefrontier, Inc..
[3256273]
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 occuring. Facetfuse screws were implanted into a pt on (b)(6) 2008. On (b)(6) 2009, the implanting surgeon communicated that during pt follow up it was noted that two facetfuse screws had pulled out of the implant site. The pt was revised and it was noted during revision that there was delayed fusion or non-union of the facet joints. General pt info: elderly male with degenerative disc disease and poor bone quality, requiring fixation/fusion at l4-l5.
Patient Sequence No: 1, Text Type: D, B5
[10589288]
It was noted during investigation that pt revision revealed delayed/non-union of the facet joint fusion. Risk associated with device performance when subjected to non-union are sufficiently addressed in device labeling. It was also reported by spinfrontier clinical personnel, who assessed the pt's condition prior to implant, that it was recommended that the facet fixation be made in conjunction with an intervertebral body fusion (ibf) device. The fixation was not performed accordingly and, therefore, the facet screws were likely exposed to higher load bearing forces than they would have in conjunction with an ibf device. Facetfuse package insert indicates that "internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs". This indicates that the device is intended as a temporary solution until fusion occurs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005977257-2013-00010 |
| MDR Report Key | 3020986 |
| Report Source | 07 |
| Date Received | 2013-03-20 |
| Date of Report | 2013-03-13 |
| Date of Event | 2009-02-09 |
| Date Mfgr Received | 2009-02-09 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2013-05-22 |
| 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 | 9782323990 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FACETFUSE SCREWS |
| Generic Name | FACET SCREWS |
| Product Code | MRW |
| Date Received | 2013-03-20 |
| Model Number | IM0006 |
| Lot Number | 92906 |
| 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, INC. |
| 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 |