MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-17 for IVORY CLAMP IVORY CLAMP SS2A REG BICUSPID, 50057312 manufactured by Heraeus Kulzer, Llc.
[20375763]
Email received from (b)(6), quality event form. Describes broken clamp event one day prior. Clamp broke in half while in patient's mouth, pieces were retrieved, neither patient nor staff members were injured. Clamp is being returned to (b)(6) and will be forwarded to hkna. This malfunction is reportable as sec. 803. 50 states if you are a manufacturer, you must report to us no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. The malfunction will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.
Patient Sequence No: 1, Text Type: D, B5
[20534539]
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. Analysis of returned broken clamp: item evaluated: ivory clamp style ss 2a reg bicuspid, lot no. :a2, manufacture date:9/30/2012, receipt date: 02/09/2015. Complaint: broken. Evaluation summary: the clamp has multiple damage points and an excessive damage area on the top side of the jaw, by a dental grinding tool. The clamp broke in the mid-bow area. The break was uneven and not parallel to a stencil or lot number character. The user's grinding marks were evident on the jaw of the clamp. With pieces reassembled with a smooth seam, overextension is apparent. This bicuspid clamp may have been used on a molar. It shows heavy use and has what appears to be cement covering most of the surfaces. The dfu states, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage. " and, the directions state, "do not place clamp in mouth until the rubber dam has been properly placed. Clamp could become a choking or safety hazard if dropped or broken in the mouth without proper use of the rubber dam at all times. " cause of breakage: misuse by user due to damage by overextension. Conclusion: the complaint is not confirmed due to user misuse. 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 | 1925223-2015-00007 |
| MDR Report Key | 4520183 |
| Report Source | 05 |
| Date Received | 2015-02-17 |
| Date of Report | 2015-01-29 |
| Date of Event | 2015-01-28 |
| Date Mfgr Received | 2015-01-30 |
| Date Added to Maude | 2015-02-17 |
| 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 | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. RITA ROGERS |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER, LLC |
| 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 | CLAMP, RUBBER DAM |
| Product Code | EEF |
| Date Received | 2015-02-17 |
| Returned To Mfg | 2015-02-09 |
| Model Number | IVORY CLAMP SS2A REG BICUSPID, |
| Catalog Number | 50057312 |
| Device Expiration Date | 2017-09-30 |
| Operator | DENTAL ASSISTANT |
| Device Availability | R |
| 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 46614251 US 46614 2517 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-17 |