MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-05-31 for RESPOND REDUCTION SCREW 8 DEGREE 50MM 01-80016-50 manufactured by Spinefrontier, Inc..
[17880093]
Surgeon put in an 8. 0x50mm respond (reduction screw) in the pt and then realized that he didn't get the screw placement in deep enough. Surgeon was unable to remove the screw after several attempts.
Patient Sequence No: 1, Text Type: D, B5
[18053480]
Surgeon did not place screw deep enough and then tried removing it by backing it out using a tool not intended for that use. This resulted in bending of this instrument which prevented removal of the screw. Surgeon then tried using a locking driver assembly instrument to remove the screw which resulted in the tip of the driver breaking. Broken tip was removed and surgeon was unable to successfully remove the screw. No harm was done to the pt and no follow-up treatment was necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005977257-2012-00007 |
| MDR Report Key | 2602481 |
| Report Source | 07 |
| Date Received | 2012-05-31 |
| Date of Report | 2012-05-31 |
| Date of Event | 2012-03-12 |
| Date Mfgr Received | 2012-03-13 |
| Date Added to Maude | 2012-08-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 500 CUMMINGS CENTER SUITE 3500 |
| Manufacturer City | BEVERLY MA 01915 |
| Manufacturer Country | US |
| Manufacturer Postal | 01915 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESPOND REDUCTION SCREW |
| Generic Name | RESPOND REDUCTION SCREW |
| Product Code | MRW |
| Date Received | 2012-05-31 |
| Model Number | 8 DEGREE 50MM |
| Catalog Number | 01-80016-50 |
| ID Number | 79052767 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINEFRONTIER, INC. |
| Manufacturer Address | BEVERLY MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-31 |