MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH RELYX UNICEM 2 CEMENT; DENTAL CEMENT

Catalog Number 56874

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

Additional reports will be made for the other patients with lava ultimate crowns in this practice who required tooth extraction.Since this event involved four medical devices, four manufacturer reports are being submitted.Suspect medical device section of this report describes the second device.Suspect medical device section of manufacturer report numbers 3005174370-2015-00095, 9611385-2015-00060 and 9611385-2015-00061, describe the first, third and fourth device, respectively.

Event Description

On (b)(6) 2015, a representative from a dental office reported that patients with 3m espe lava ultimate cad/cam restorative crowns required tooth extraction.Follow-up information provided by the office on (b)(6) 2015, detailed the case of a (b)(6) female patient who received a lava ultimate cad/cam restorative for cerec crown on tooth #30 secured with 3m espe scotchbond universal adhesive, 3m espe relyx ultimate adhesive resin cement and 3m espe relyx unicem 2 cement on (b)(6) 2012.No information was provided to indicate how the decay under the crown was identified; the office notes that the decay was to an extent that the tooth was not salvageable.The tooth was extracted on (b)(6) 2015.

• Brand Name: RELYX UNICEM 2 CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH-SEEFELD; espe platz; seefeld, D8222 9; GM D82229
• Manufacturer Contact: thomas meindl ; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• MDR Report Key: 5196454
• MDR Text Key: 30202595
• Report Number: 9611385-2015-00059
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 56874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2015
• Initial Date FDA Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR