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

Model Number	ILDAT5
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Age and date of birth unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.Date of event unknown / not provided.
Event or Problem Description
It was reported that abutment kept coming loose in patients mouth, would not stay engage with implant (ill-fitting).Not part of the recall.Tooth #13.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
The following sections have been updated: b4: date of this report.D1: brand name.D2: type of the device.D4: catalog number.D4: lot/serial #.D4: device expiration date.D4: device udi number.D9: device availability.G3: date received by manufacturer.G4: pma/510(k) number.G6: checked "follow-up".H2: checked follow-up type.H4: device manufacturer date.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One certain® gold-tite® hexed screw (iunihg) and associated abutment/crown were returned for investigation.The complaint alleged that the abutment kept coming loose in the patient¿s mouth.Visual evaluation of the as returned products identified signs of wear around the screw hex but no apparent signs of malfunction.Additionally, the screw devices and crown were still engaged.Functional testing could not be performed since the devices and crown were still engaged.Therefore, device malfunction could not be verified/confirmed.No pre-existing conditions were noted.The devices had been placed on tooth #13 for an unknown period of time.X-ray or picture images were not provided.Appropriate documentation was reviewed.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 (1223789) 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 number (1223789) for similar events (complaint category keywords: loosening) and no other complaint was identified.Based on the available information, device malfunction could not be verified.Additionally, the reported event could not be verified as the exact details of event were nonverifiable.

• Brand Name: CERTAIN GOLD-TITE HEXED SCREW
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11392741
• Report Number: 0001038806-2021-00357
• Device Sequence Number: 3120998
• Product Code: NHA
• UDI-Device Identifier: 00844868031413
• UDI-Public: (01)00844868031413(10)8467407-1
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: ILDAT5
• Device Catalogue Number: IUNIHG
• Device Lot Number: 1223789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 06/28/2021; 07/15/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 06/28/2021; 07/15/2021
• 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