MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2013-12-12 for IVORY CLAMP 4 50057324 manufactured by Heraeus Kulzer, Inc., Dental Products Division.
[4304878]
This is the second of two reports for two separate devices from the same office. Dealer rep called and said she received from the local rep 3 clamps. There was no description of the complaint; however, all 3 clamps are broken. She gave the office info and said she would return the clamps. One of the clamps had exceeded the use life as defined in the labeling. Spoke to an assistant at the office. She said that they do not remember which patient's clamps broke on. She said that they broke while putting them on the tooth or during the procedure. She said that no one was injured.
Patient Sequence No: 1, Text Type: D, B5
[11810271]
Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Eval summary: the clamp is damaged by dental grinder marks in the jaw area and on the bow of the clamp. Also it is distorted from its original shape. When reassembled it was obviously permanently deformed, not returning to its original formed shape and jaw proximity. Conclusion: overextension probably caused permanent deformation to the clamp and subsequently breakage of the clamp. Excessive dental grinder damage is also a possible factor leading to breakage of the clamp. Due to the aforementioned fact that this was customer misuse, no further action is deemed necessary at this time. The investigation is closed. Capa measures are not proposed or initiated. The dental office said that no one was injured during the incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925223-2013-00171 |
| MDR Report Key | 3733786 |
| Report Source | 05,08 |
| Date Received | 2013-12-12 |
| Date of Report | 2012-11-12 |
| Date Mfgr Received | 2013-11-12 |
| Date Added to Maude | 2014-05-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | AUDI BOGUCKI, RDH |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 466142517 |
| Manufacturer Country | US |
| Manufacturer Postal | 466142517 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614251 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 2517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IVORY CLAMP |
| Generic Name | EEF CLAMP, RUBBER DAM |
| Product Code | EEF |
| Date Received | 2013-12-12 |
| Returned To Mfg | 2013-11-26 |
| Model Number | 4 |
| Catalog Number | 50057324 |
| Lot Number | Y1 |
| Device Expiration Date | 2016-06-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION |
| Manufacturer Address | 300 HERAEUS WAY. SOUTH BEND IN 46614251 US 46614 2517 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-12 |