MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-21 for 301 ELEV. DEL301 manufactured by Integra York, Pa Inc..
[146488359]
The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed. A failure analysis and determination of root cause is not possible due to the lack of information received to perform a complete investigation. Product has not been returned. The reported complaint is unconfirmed. Device identifier: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146488360]
It was reported that on (b)(6) 2019, while using a del301 301 elevator, the tip broke off between the patient? S tooth and gum. The doctor had to use another elevator to remove the tip. There was no patient injury or surgical delay reported. Additional request for information has been sent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00070 |
| MDR Report Key | 8629191 |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-06 |
| Date of Event | 2019-05-06 |
| Date Mfgr Received | 2019-05-30 |
| Device Manufacturer Date | 1999-03-01 |
| Date Added to Maude | 2019-05-21 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 301 ELEV. |
| Generic Name | M51 - GENERAL DENTISTRY |
| Product Code | EMJ |
| Date Received | 2019-05-21 |
| Returned To Mfg | 2019-05-29 |
| Catalog Number | DEL301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-21 |