MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-24 for BUR TREPHINE35TL 2ID 2.8O 04948001 manufactured by Ace Surgical Supply Company.
[180531687]
Trephine bur was abruptly stopped while motor continued to turn causing bur to shear into two pieces.
Patient Sequence No: 1, Text Type: N, H10
[180531688]
Per assistant at the office, she said that they were performing an implant removal procedure when the product broke in half inside a patient's mouth. The patient was not injured and the piece was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1287163-2020-82419 |
| MDR Report Key | 9743856 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-24 |
| Date of Report | 2020-01-29 |
| Date of Event | 2019-11-20 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2020-02-24 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS DOREEN PRICE |
| Manufacturer Street | 1034 PEARL STREET |
| Manufacturer City | BROCKTON MA 02301 |
| Manufacturer Country | US |
| Manufacturer Postal | 02301 |
| Manufacturer Phone | 8004413100 |
| Manufacturer G1 | ACE SURGICAL SUPPLY COMPANY |
| Manufacturer Street | 1034 PEARL STREET |
| Manufacturer City | BROCKTON MA 02301 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUR TREPHINE35TL 2ID 2.8O |
| Generic Name | BUR TREPHINE |
| Product Code | EJL |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-01-17 |
| Model Number | 04948001 |
| Catalog Number | 04948001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACE SURGICAL SUPPLY COMPANY |
| Manufacturer Address | 1034 PEARL STREET BROCKTON MA 02301 US 02301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-24 |