MAUDE Adverse Event Report: ZIMMER DENTAL 3.5 EMERGENCE, 1.5MM CUFF; ABUTMENT

Catalog Number CEANP31

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Device lot number not provided/unknown.Device not returned.

Event Description

It was reported that the abutment (ceanp31) loosened in the patient's mouth.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

No product was returned for inspection.No device lot number was provided so a device history record review and a complaint history review could not be performed.Without the returned product, there is not enough evidence to form a conclusion on the reported event.Therefore, the complaint is non-verifiable.A root cause cannot be determined.

• Brand Name: 3.5 EMERGENCE, 1.5MM CUFF
• Type of Device: ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• MDR Report Key: 7971154
• MDR Text Key: 124144373
• Report Number: 0002023141-2018-00849
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: PK143528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: CEANP31
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/16/2018
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 03/06/2019
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 77