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

Model Number	ILRGHG
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient identifier unknown / not provided.Weight unknown / not provided.Email address unknown / not provided.Pma/510(k) number:k072642.
Event or Problem Description
It was reported crown mobility, when check up doctor noticed screw loosening.New screw placed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One certain® gold-tite® large hexed screws (ilrghg) was returned for investigation.Visual evaluation of the as returned screw identified signs of use but no apparent malfunction.Functional testing was performed and the screws were able to thread into and out of applicable in-house implant.No pre-existing conditions were reported.The device had been placed for approximately 1 year.X-ray or picture images were not provided.Review of appropriate documentation: documents reviewed: biomet 3i restorative products ifu (p-iis086gr) rev f - october 2019.Information identified: warnings, precautions and potential adverse events.Per the applicable ifu, under section (precautions), it is stated that improper technique could cause screw loosening.Also, according to the ifu, patient factors like presence of occlusal abnormalities or parafunctional habits (e.G.Severe bruxism, clenching, overloading, or gnawing) may cause screw loosening, restoration fracture, and/or implant failure.Dhr review for the lot (1223329) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot (1223329) and no similar event or complaint was found.Post market trending review: october post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information and functional testing, device malfunction did not occur.However, the reported event could not be verified as the exact details of event were nonverifiable.

• Brand Name: CERTAIN GOLD-TITE LARGE HEXED SCREW
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10683363
• Report Number: 0001038806-2020-01568
• Device Sequence Number: 19610329
• Product Code: DZE
• UDI-Device Identifier: 00844868006121
• UDI-Public: (01)00844868006121(17)231205(10)1223329(241)ILRGHG
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K972444
• 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): 12/21/2020

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: 12/05/2023
• Device Model Number: ILRGHG
• Device Catalogue Number: ILRGHG
• Device Lot Number: 1223329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR