MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-09-20 for INDUS INVUE TAPERED TIPPED DRIVER 11-70096 manufactured by Spinefrontier, Inc..
[2886220]
Please note, this event was erroneously filed on a form 3500 with errors on (b)(6) 2012 by former personnel of spinefrontier. This is the corrected version of events, on the correct form 3500a, and filed per discussion with (b)(4) at the mdr reporting office of the fda on 09/11/2012. This is the identical problem encountered on mdr 3005977257-2012-00001. Surgeon was surgically implanting indus invue anterior cervical plate system using the tipped driver to insert the fixation screws. He was having difficulty retaining the screws on the tip of the driver, which made inserting the screws difficult. This did not add time to the surgery, or cause any harm to the pt, as the surgeon had another driver present to use and complete the insertion of the screws. However, if another driver were not available to the surgeon, this could have led to an increase in surgical time, putting the pt at risk.
Patient Sequence No: 1, Text Type: D, B5
[10140411]
Because the issue in this report is identical to the issue in mdr 3005977257-2012-00001, the add? L info added here is the same as on that mdr. The issue with the indus invue drivers is that the tip of the driver and the head of the screw did not have a tight enough fit. Engineering worked solutions to solve this issue, with the conclusion being the release of an updated driver with a tip and screw head that fit better. The issue with the drivers and screws was clear to spinefrontier, so the solution was arrived at without reviewing the malfunctioned instrument used in this case. Although this type of event is not typically reported on an mdr, we are submitting this for two reasons: this event was captured on a form 3500 by a former employee that did not realize that this event may not have been reportable, and the issue with this driver did recur more than one time in the coming months, which necessitated making a change in the driver design.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005977257-2012-00002 |
| MDR Report Key | 2765512 |
| Report Source | 07 |
| Date Received | 2012-09-20 |
| Date of Report | 2012-09-12 |
| Date of Event | 2012-04-11 |
| Date Mfgr Received | 2012-04-03 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2012-10-10 |
| 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 Contact | MATTHEW KING |
| 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 | INDUS INVUE TAPERED TIPPED DRIVER |
| Generic Name | TAPERED TIPPED DRIVER |
| Product Code | MRW |
| Date Received | 2012-09-20 |
| Model Number | 11-70096 |
| Lot Number | 012020-001 |
| 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 | 100 CUMMINGS CENTER SUITE 240C BEVERLY MA 01915 US 01915 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-20 |