MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-09-14 for IVORY CLAMP SS 14A REG MOLAR 50057356 manufactured by Heraeus Kulzer, Llc.
[54761056]
This incident occurred in (b)(6). The office was using hu-friedy forceps, which can lead to hyperextension and excessive forces being placed on the bow of the ivory clamp. These forces and hyperextension can lead to the breakage of the clamp. Also noticed during the evaluation in the breakage area were a couple of small voids in the metal that could have contributed to this breakage. Due to the forceps used as described and the possible voids, this incident is impossible to conclude with 100% certainty which factor caused the malfunction.
Patient Sequence No: 1, Text Type: N, H10
[54761057]
Clamp broke the first time in use. Clamp broke while on the forceps, getting ready to place into the mouth. Clamp broke outside of the patient's mouth. Office is using hu-friedy forceps (non heraeus kulzer forceps). A rubber dam was not being utilized for the procedure. Clamp was only ligated on one side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1821514-2016-00027 |
| MDR Report Key | 5951685 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-09-14 |
| Date of Report | 2016-09-12 |
| Date of Event | 2016-08-01 |
| Date Mfgr Received | 2016-08-16 |
| Device Manufacturer Date | 2015-10-01 |
| Date Added to Maude | 2016-09-14 |
| 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 | MRS. AMBER BROWN |
| Manufacturer Street | 4315 LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995411 |
| Manufacturer G1 | HERAEUS KULZER, LLC |
| Manufacturer Street | 4315 LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND IN 466142517 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 466142517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IVORY CLAMP SS 14A REG MOLAR |
| Generic Name | RUBBER DAM CLAMP |
| Product Code | EEF |
| Date Received | 2016-09-14 |
| Returned To Mfg | 2016-09-06 |
| Catalog Number | 50057356 |
| Lot Number | M5 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER, LLC |
| Manufacturer Address | 4315 LAFAYETTE BLVD. SOUTH BEND IN 466142517 US 466142517 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-14 |