MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-04-09 for HENRY SCHEIN INC CSET02G10FZ775X 900-4368 manufactured by Prima Dental Group.
[141338238]
Eight (8) samples from the reported lot no were returned to prima dental group for evaluation. Visual inspection carried out by the qa dept confirmed all 8 to be in a good condition with no obvious signs of damage and/or deterioration. Using a calibrated 0-25mm external digital mircometer (asset no dm002, last calibrated 02/01/2019, calibration due date 05/01/2019), each of the 8 burs were measured in 2 places across the od of the shank. The results obtained are as shown below. Shank od specification - 1. 590 to 1. 600mm: sample #1 - 1. 595/1. 596, sample #2 - 1. 595/1. 596, sample #3 - 1. 595/1. 596, sample #4 - 1. 595/1. 596, sample #5 - 1. 595/1. 596, sample #6 - 1. 595/1. 596, sample #7 - 1. 595/1. 596, sample #8 - 1. 595/1. 596. As a secondary test the burs were checked for fit and performance using a ss white hand piece (e0151). In each case the burs locked securely into the hand piece and when tested on macor, a machineable glass ceramic, performed as per intended by the manufacturer. In order to ascertain more details about the procedure being conducted at the time of the reported incidents and the condition of the hand piece itself, a product deviation report (frm-12. A0) was sent to the importer for forwarding to the user. Unfortunately no details regarding the type and condition of the hand piece (ref service history) were provided. From the findings of our investigation we could find no fault with any of the burs returned in support of the complaint. The dhr for the lot no indicated no problems were experienced during the manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
[141338240]
While delivering a crown on a (b)(6) male patient, the entire bur fell out of the hand piece into the patients mouth. The patient swallowed the bur and was sent for an x-ray. The dr confirmed the patient was fine and no additional medical attention was required. The dr stated there were no changes in the patient's condition reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003444492-2019-00001 |
| MDR Report Key | 8495603 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-09 |
| Date of Report | 2019-02-05 |
| Date of Event | 2019-01-10 |
| Date Facility Aware | 2019-01-22 |
| Report Date | 2019-02-05 |
| Date Reported to FDA | 2019-02-05 |
| Date Reported to Mfgr | 2019-02-05 |
| Date Mfgr Received | 2019-02-05 |
| Device Manufacturer Date | 2018-11-15 |
| Date Added to Maude | 2019-04-09 |
| 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 | MR ALAN FOWLER |
| Manufacturer Street | STEPHENSON DRIVE |
| Manufacturer City | GLOUCESTER, GL2 2HA |
| Manufacturer Country | UK |
| Manufacturer Postal | GL2 2HA |
| Manufacturer G1 | PRIMA DENTAL GROUP |
| Manufacturer Street | STEPHENSON DRIVE |
| Manufacturer City | GLOUCESTER, GL2 2HA |
| Manufacturer Country | UK |
| Manufacturer Postal Code | GL2 2HA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HENRY SCHEIN INC |
| Generic Name | CARBIDE ROTARY DENTAL BUR |
| Product Code | EJL |
| Date Received | 2019-04-09 |
| Returned To Mfg | 2019-01-31 |
| Model Number | CSET02G10FZ775X |
| Catalog Number | 900-4368 |
| Lot Number | 1165450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRIMA DENTAL GROUP |
| Manufacturer Address | STEPHENSON DRIVE GLOUCESTER, GL2 2HA UK GL2 2HA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2019-04-09 |