MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-12-20 for IVORY CLAMP 13A 50057352 manufactured by Heraeus Kulzer Llc.
[15116700]
A (b)(6) dealer notified us of a clamp that was returned for credit because it broke on the first use. Requested add'l info from the dealer. Dealer has not responded to the request.
Patient Sequence No: 1, Text Type: D, B5
[15340832]
Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr 803 and out of an abundance of caution. Evaluation 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. Cause of breakage: misuse. Conclusion: overextension 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925223-2013-00173 |
| MDR Report Key | 3766105 |
| Report Source | 01,08 |
| Date Received | 2013-12-20 |
| Date of Report | 2013-12-02 |
| Date Mfgr Received | 2013-12-02 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2014-05-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | AUDI BOGUCKI, RDH |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IVORY CLAMP |
| Generic Name | CLAMP, RUBBER DAM |
| Product Code | EEF |
| Date Received | 2013-12-20 |
| Returned To Mfg | 2013-12-04 |
| Model Number | 13A |
| Catalog Number | 50057352 |
| Lot Number | J3 |
| Device Expiration Date | 2018-01-31 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER LLC |
| Manufacturer Address | 300 HERAEUS WAY SOUTH BEND IN 46614 US 46614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-20 |