MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-03-26 for X-SMART IQ CONTRA ANGLE H105900000000 manufactured by Tulsa Dental Products Llc.
[185231404]
This malfunction can cause file separation. Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur. As such, this event meets the criteria for reportability per 21 cfr part 803. Unusual torque developed during rotation, since overhaul was not possible, a new handpiece was given to the customer.
Patient Sequence No: 1, Text Type: N, H10
[185231405]
In this event it was reported that the torque of a x-smart iq applied by itself (improperly auto-reversing); no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031010-2020-00048 |
| MDR Report Key | 9885551 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-26 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 8494424 |
| Manufacturer G1 | ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L. |
| Manufacturer Street | VIA SAN DONATO 1 |
| Manufacturer City | PISTOIA, 51100 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 51100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | X-SMART IQ CONTRA ANGLE |
| Generic Name | CONTROLLER, FOOT, HANDPIECE AND CORD |
| Product Code | EBW |
| Date Received | 2020-03-26 |
| Model Number | NA |
| Catalog Number | H105900000000 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TULSA DENTAL PRODUCTS LLC |
| Manufacturer Address | 608 ROLLING HILLS DRIVE JOHNSON CITY, TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |