MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-19 for NEWBRIDGE LFS 40-1003 manufactured by Orthofix Inc.
[36962228]
Information provided states that the screwdriver was stripped and could not be used to insert the screws resulting in a delay in the procedure. Patient is recovering well.
Patient Sequence No: 1, Text Type: D, B5
[39872286]
The device was returned and evaluated. The hex tip shows slight rounding on the edges. Repeated use can cause the edges to wear down. The screw driver was functionally tested with a lateral mass screw and the driver would not grab the screw. This instrument has been in the field since 2009.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008524126-2015-00041 |
| MDR Report Key | 5378829 |
| Date Received | 2016-01-19 |
| Date of Report | 2016-03-04 |
| Date of Event | 2015-12-18 |
| Date Mfgr Received | 2015-12-21 |
| Date Added to Maude | 2016-01-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. YOLANDA THOMPSON |
| Manufacturer Street | 3451 PLANO PARKWAY |
| Manufacturer City | LEWISVILLE TX 75056 |
| Manufacturer Country | US |
| Manufacturer Postal | 75056 |
| Manufacturer Phone | 2149372291 |
| Manufacturer G1 | ORTHOFIX INC |
| Manufacturer Street | 3451 PLANO PARKWAY |
| Manufacturer City | LEWISVILLE TX 75056 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75056 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEWBRIDGE LFS |
| Generic Name | 2.5MM LATERAL MASS SCREWDRIVER |
| Product Code | NQW |
| Date Received | 2016-01-19 |
| Model Number | 40-1003 |
| Lot Number | 16836-LE29 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX INC |
| Manufacturer Address | 3451 PLANO PARKWAY LEWISVILLE TX 75056 US 75056 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-19 |