MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH PROTEMP PLUS; CROWN AND BRIDGE, TEMPORARY, RESIN

Catalog Number 46955

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 07/25/2016

Event Type  Injury  

Manufacturer Narrative

No protemp plus sample returned for analysis and no lot number provided.Thus no further investigation can be completed.This event involved three medical devices, therefore three manufacturer reports are being submitted to fda.Suspect medical device part of this current report described the third medical device.Suspect medical device part of manufacturer reports 3005174370-2016-00085 and 9611385-2016-00010 describe the first and second medical device, respectively.

Event Description

On (b)(6) 2016, a dental assistant informed 3m that a (b)(6) male patient required a root canal due to unresolved sensitivity.The patient initially had a restorative treatment using 3m espe filtek z250 restorative and 3m espe scotchbond universal adhesive on (b)(6) 2016.The patient returned to the office on (b)(6) 2016 experiencing sensitivity and pain and the restorative was replaced using a non-3m liner followed by 3m espe filtek z250 restorative and 3m scotchbond universal adhesive again.The pain continued and on (b)(6) 2016, the patient saw an endodontist and was diagnosed with irreversible pulpitis and was recommended for a temporary crown.On (b)(6) 2016, the dental office placed a temporary crown using 3m espe protemp plus with a non-3m brand cement.On (b)(6) 2016 the patient reported that the pain had worsened and on (b)(6) 2016, the root canal was performed.

Manufacturer Narrative

Suspect medical device part of manufacturer reports 3005174370-2016-00086 and 9611385-2016-00010 describe the first and second medical device, respectively.

Event Description

On october 6, 2016, the dental office reported that the patient was doing well.

• Brand Name: PROTEMP PLUS
• Type of Device: CROWN AND BRIDGE, TEMPORARY, RESIN
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; carl-schurz-strasse 1; neuss, 41453 ; GM 41453
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH-SEEFELD; espe platz; seefeld, 82229 ; GM 82229
• Manufacturer Contact: thomas meindl ; carl-schurz-strasse 1; neuss, 41453 ; GM 41453
• MDR Report Key: 5905476
• MDR Text Key: 53062577
• Report Number: 9611385-2016-00011
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 46955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR