MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-03-23 for IVORY CLAMP IVORY CLAMP SS W8A WNGLSS MOLAR 50057536 manufactured by Heraeus Kulzer, Llc.
[40960502]
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. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[40960503]
By way of dealer rep from (b)(4), complaint that clamp broke on first use. The office used a competitor's brand forceps.
Patient Sequence No: 1, Text Type: D, B5
[45322894]
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. Item evaluated: ivory clamp ss w8a wnglss molar, lot no. : c3, manufacture date: 7/2013, receipt date: 4/01/2016. Complaint: broke on first use. Evaluation summary: two pieces of the clamp were received for analysis. Returned with the broken pieces was a clamp bag of a different, younger lot number. The clamp broke in the right hole area, looking down on the bow with claws to the front. With pieces reassembled with a smooth seam, overextension and torquing are apparent. When compared to standard samples, the overextension is obvious. The da also stated they used premier forceps. The dfu states, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage. " 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
[45322895]
By way of dealer rep from (b)(4), complaint that clamp broke on first use. The office used a competitor's brand forceps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1821514-2016-00010 |
| MDR Report Key | 5519631 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-03-23 |
| Date of Report | 2016-02-25 |
| Date Mfgr Received | 2016-02-25 |
| Device Manufacturer Date | 2015-01-28 |
| Date Added to Maude | 2016-03-23 |
| 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 | 3 |
| Event Location | 3 |
| 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 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 |
| Generic Name | CLAMP, RUBBER DAM |
| Product Code | EEF |
| Date Received | 2016-03-23 |
| Returned To Mfg | 2016-04-01 |
| Model Number | IVORY CLAMP SS W8A WNGLSS MOLAR |
| Catalog Number | 50057536 |
| Lot Number | C3 |
| Device Expiration Date | 2019-01-28 |
| Operator | DENTAL ASSISTANT |
| Device Availability | R |
| Device Age | 1 YR |
| 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 466142517 US 466142517 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-23 |