MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2015-05-14 for IVORY CLAMP IVORY CLAMP SS 12A REG MOLAR 50057348, manufactured by Heraeus Kulzer, Llc.
[21087971]
Reported by (b)(6) of (b)(6): ivory clamp ss 12a reg molar snapped at (b)(6) dental clinic. Called and spoke with (b)(6), who stated both clamps were new, patients were involved (see also (b)(4)), but no one was injured. (b)(6) stated the office uses a variety of rubber dam forceps: (b)(4). Advised (b)(6) that ivory brand forceps are manufactured to specifications of the clamp extension. Other forceps may allow the prongs to open too far and hyper extend the wings of the clamp, potentially leading to fracture. This clamp breakage occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[21217487]
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. Distorting the clamp during usage causing breakage of the clamp. Device breakage is addressed in the directions for use. 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. " the directions for use warns, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage. " the user twisted and bent the clamp in a manner that is contraindicated. The directions contain adequate warning and instructions. Over-extension of the clamp caused permanent deformation to the clamp and subsequently breakage of the clamp.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925223-2015-00020 |
| MDR Report Key | 4772335 |
| Report Source | 01,05,08 |
| Date Received | 2015-05-14 |
| Date of Report | 2015-04-20 |
| Date Mfgr Received | 2015-04-20 |
| Device Manufacturer Date | 2010-07-31 |
| Date Added to Maude | 2015-06-15 |
| 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 | 2015-05-14 |
| Returned To Mfg | 2015-05-06 |
| Model Number | IVORY CLAMP SS 12A REG MOLAR |
| Catalog Number | 50057348, |
| Lot Number | C0 |
| Device Expiration Date | 2015-07-31 |
| 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 | 2015-05-14 |