MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-12 for PILLAR SA PTC 49-1109 manufactured by Orthofix Inc..
[102447257]
Information provided states that during an l5-s1 anterior fusion case the tip broke off of the drill bit. The surgeon determined that the tip was securely imbedded in the bone and did not pose a risk of migration. A 5 mm portion of the drill bit remains in patients' l5 vertebra.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183449-2018-00004 |
| MDR Report Key | 7329950 |
| Date Received | 2018-03-12 |
| Date of Report | 2018-03-09 |
| Date of Event | 2018-02-15 |
| Date Mfgr Received | 2018-02-16 |
| Date Added to Maude | 2018-03-12 |
| 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 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 | 0 |
| Brand Name | PILLAR SA PTC |
| Generic Name | PILLAR SA DRILL BIT |
| Product Code | DZJ |
| Date Received | 2018-03-12 |
| Model Number | 49-1109 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-03-12 |