MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-19 for HU-FRIEDY PERIOTOME manufactured by Hu-friedy Mfg. Co., Llc.
[3657987]
During a dental procedure involving upper implants and extraction of number 4 tooth, a tip of a periotome broke off in the socket and was not located during the procedure. After the procedure, x-ray taken identified the periotome tip was found in the sinus. A later cat scan of the sinus was reviewed by ent who reported that the linear metallic opacity was confined to soft tissue right premaxilla with superior portion extending to level of infraorbital nerve. Surgery is being planned to remove the tip.
Patient Sequence No: 1, Text Type: D, B5
[10895321]
Information was collected from medwatch form 3500 provided by the institution. The manufacturing date is not known because the instrument was not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2013-00003 |
| MDR Report Key | 3247581 |
| Report Source | 06 |
| Date Received | 2013-07-19 |
| Date of Report | 2013-07-16 |
| Date of Event | 2013-05-13 |
| Date Mfgr Received | 2013-07-15 |
| Date Added to Maude | 2013-08-01 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA VRABLE |
| Manufacturer Street | 3232 NORTH ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDY PERIOTOME |
| Generic Name | PERIOTOME |
| Product Code | EMG |
| Date Received | 2013-07-19 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Address | 3232 NORTH ROCKWELL ST. CHICAGO IL 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-19 |