MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-16 for AMAL CAR. D/E LGE/JUM STE 71-66 manufactured by Integra York, Pa Inc..
[90578499]
10/3/17 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - a carrier was returned in used condition, not showing any unusual markings. It was noticed that the lever is broken and the barrel is detached. The complaint report is confirmed; damaged worn. Device history evaluation - nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: none. Corrective action preventive action history/corrections: none. Health hazard evaluation history: none. Conclusion: the root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
[90578500]
Customer initially reports broken levers and tips. No patient injury. (b)(6) 2017 customer reports the lever broke when filling a molar and fell into patients mouth, piece was retrieved, no harm done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00107 |
| MDR Report Key | 6951810 |
| Date Received | 2017-10-16 |
| Date of Report | 2017-09-22 |
| Date of Event | 2017-09-21 |
| Date Mfgr Received | 2017-10-02 |
| Date Added to Maude | 2017-10-16 |
| 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 | USER SANDRA LEE |
| 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 | AMAL CAR. D/E LGE/JUM STE |
| Generic Name | M51 - GENERAL DENTISTRY |
| Product Code | EKI |
| Date Received | 2017-10-16 |
| Returned To Mfg | 2017-09-27 |
| Catalog Number | 71-66 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-10-16 |