MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-16 for IVORY CLAMP IVORY CLAMP SS2A REG BICUSPID 50057312 manufactured by Heraeus Kulzer, Llc.
[5537113]
(b)(6). We have an ivory rubber dam starter kit, and one of the molar clamps has broken. Are you able to assist in getting it replaced by an chance? The item number for the kit is #50057968, but i am not sure of the item number for the individual clamp. Look forward to hearing from you. Thank you, dental staff further information regarding incident and date was not provided. 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
[12829390]
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: clamp style ss 2a reg bicuspid, receipt date: (b)(4) 2015. Complaint: broken. Evaluation summary: only a fragment of the clamp was received for analysis. The clamp has damaged area on the top side of the jaw by a dental grinding tool. The clamp broke in the bow area. The user's grinding marks were evident on the jaw of the clamp. 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 dental grinding tool. 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 | 1925223-2015-00005 |
| MDR Report Key | 4519486 |
| Report Source | 05 |
| Date Received | 2015-02-16 |
| Date of Report | 2015-01-22 |
| Date Mfgr Received | 2015-01-22 |
| Date Added to Maude | 2015-03-19 |
| 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 466142517 |
| Manufacturer Country | US |
| Manufacturer Postal | 466142517 |
| 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 | 2015-02-16 |
| Returned To Mfg | 2015-01-30 |
| Model Number | IVORY CLAMP SS2A REG BICUSPID |
| Catalog Number | 50057312 |
| Operator | OTHER |
| 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 | 2015-02-16 |