MAUDE Adverse Event Report: HERAEUS KULZER, LLC IVORY CLAMP; CLAMP, RUBBER DAM

Catalog Number 50057310

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Narratives: 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 clamp had been severely torqued and hyperextended, leading to metal fatigue.

Event Description

This complaint is from (b)(6).Dealer returned broken clamp.

• Brand Name: IVORY CLAMP
• Type of Device: CLAMP, RUBBER DAM
• Manufacturer (Section D): HERAEUS KULZER, LLC; 300 heraeus way; south bend IN 46614 2517
• Manufacturer (Section G): HERAEUS KULZER, LLC; 300 heraeus way; south bend IN 46614 2517
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 5669378
• MDR Text Key: 45596054
• Report Number: 1821514-2016-00015
• Device Sequence Number: 1
• Product Code: EEF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 09/28/2018
• Device Catalogue Number: 50057310
• Device Lot Number: A3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1