MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H); DENTAL ABUTMENT

Model Number	ILPC342U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).First/given name: unknown / not provided.
Event or Problem Description
It was reported that during a check up the prosthesis was ill-fitting and when removing it, doctor noticed fracture of the abutment.
Additional Manufacturer Narrative
One abutment was returned for investigation.Visual inspection of the returned product identified that the abutment fractured.A device history review was performed and no related nonconformance¿s were noted.A complaint history search was performed using our complaint handling system and there were no additional related complaints against this lot.Appropriate documentation was reviewed.The alleged device malfunction was confirmed.A root cause cannot be determined.The following sections have been updated: b4: date of this report.G4: date received by manufacturer.G7: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9652015
• Report Number: 0001038806-2020-00229
• Device Sequence Number: 1877918
• Product Code: NHA
• UDI-Device Identifier: 00844868021100
• UDI-Public: (01)00844868021100(17)210421(10)2016040416(241)ILPC342U
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K092341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2021
• Device Model Number: ILPC342U
• Device Catalogue Number: ILPC342U
• Device Lot Number: 2016040416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 80