MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOCATOR® ABUTMENT 4.1MM(D) X 5MM(H); DENTAL ABUTMENT

Model Number	ILOA005
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.
Event or Problem Description
The laboratory reported screw fracture.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: b4: date of this report.D4:catalog number.G4: date received by manufacturer.G7: type of report, follow-up number.H2: follow up type.H10: additional narrative.Additional information received confirmed the device was previously submitted under mfr 0001038806-2020-00530.As a result, no further medwatch reports will be submitted under this file.Please refer to mfr 0001038806-2020-00530 for follow up submissions.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN® LOCATOR® ABUTMENT 4.1MM(D) X 5MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9961657
• Report Number: 0001038806-2020-00683
• Device Sequence Number: 2728562
• Product Code: DZE
• UDI-Device Identifier: 00844868006107
• UDI-Public: (01)00844868006107(17)130129(10)787673(241)ILOA005
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K012911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2020

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: 01/29/2013
• Device Model Number: ILOA005
• Device Catalogue Number: ILOA006
• Device Lot Number: 787673
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1