MAUDE Adverse Event Report: BIOMET 3I CERTAIN GOLD-TITE HEXED SCREW; DENTAL SCREW

Model Number IUNIHG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).Patient identifier unknown / not provided.Weight unknown / not provided.Email address unknown / not provided.

Event Description

It was reported that the prosthetic screw used on implant at tooth location 30 was loose and replaced in 4 opportunities.This event is intented to capture the loosening event occurred on (b)(6) 2017.On (b)(6) 2018 doctor was adviced that the torque wrench used was uncalibrated.

Event Description

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

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).A certain® gold-tite® hexed screw (iunihg) was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.Device history record (dhr) review was completed for the subject lot number (1208481).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1208481) for similar event and no other complaint was identified.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.H3 other text: product not returned.

• Brand Name: CERTAIN GOLD-TITE HEXED SCREW
• Type of Device: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11235482
• MDR Text Key: 229167880
• Report Number: 0001038806-2021-00119
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00844868008538
• UDI-Public: (01)00844868008538(17)230418(10)1208481(241)IUNIHG
• Combination Product (y/n): N
• PMA/PMN Number: K072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

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: Health Professional
• Device Expiration Date: 04/18/2023
• Device Model Number: IUNIHG
• Device Catalogue Number: IUNIHG
• Device Lot Number: 1208481
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR