MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2005-06-30 for PATTERSON BRAND CONTRA ANGLE REAMER 05825015P manufactured by Patterson Dental Co..
[21624507]
It was reported that a reamer separated in the canal during a procedure. The separated piece was retrieved without sequela.
Patient Sequence No: 1, Text Type: D, B5
[21831728]
In this incident there was no report of injury to the pt. However, as a result of this malfunction, the potential for surgical intervention exists (though inadvisable per expert opinion provided by dr to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files. The device was not returned for evaluation and the lot number is not known for retained-product testing and/or dhr review. It was reported that the reamer was used in a 1/4 turn handpiece, a possible contributing factor in the event; the reamer involved in this event is indicated for use in a 360 degrees handpiece. Please note that the same pt is involved in this event and the event documented under report number 9611053-2005-00249.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611053-2005-00250 |
| MDR Report Key | 743480 |
| Report Source | 05,08 |
| Date Received | 2005-06-30 |
| Date of Report | 2005-05-31 |
| Date of Event | 2005-05-26 |
| Date Mfgr Received | 2005-05-31 |
| Date Added to Maude | 2006-08-04 |
| 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 | 0 |
| Manufacturer Contact | DR. PATRICIA KIHN |
| Manufacturer Street | 221 W. PHILA ST., STE. 60 SUSQUEHANNA COMMERCE CENTER W. |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY VDW GMBH |
| Manufacturer Street | BAYERWALDSTRASSE 15 |
| Manufacturer City | MUNICH 81737 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 81737 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATTERSON BRAND CONTRA ANGLE REAMER |
| Generic Name | ENDODONTIC REAMER |
| Product Code | EKP |
| Date Received | 2005-06-30 |
| Model Number | NA |
| Catalog Number | 05825015P |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 731274 |
| Manufacturer | PATTERSON DENTAL CO. |
| Manufacturer Address | * ST. PAUL MN * US |
| Baseline Brand Name | PATTERSON BRAND CONTRA ANGLE REAMER |
| Baseline Generic Name | ENDODONTIC REAMER |
| Baseline Catalog No | 05825015P |
| Baseline Device Family | PATTERSON BRAND CONTRA ANGLE REAMER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-30 |