MAUDE Adverse Event Report: BIOMET 3I IMPLANT MOUNT 3.4MM(D) X 15MM(L); DENTAL MOUNT

Catalog Number MMC15

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

Zimmerbiomet complaint number: (b)(4).

Event Description

It was reported that during the implant placement process , the doctor attempted to finish screwing in the implant by hand.The mount screw spun and damaged the internal thread of the implant.Implant was removed and procedure was completed with other implant.

Manufacturer Narrative

One osseotite implant 3.25 x 13mm (osm313), cover screw and mount (mmc15) were returned for investigation.There were no allegations against the cover screw.Visual evaluation of the as returned devices identified damages around the drive feature at the implant/mount connection.Functional testing was performed and the mount could not fully seat as drive features were damaged.Device history record (dhr) could not be reviewed for the mmc15 since the lot number was unknown.A complaint history review by item number was conducted for the (mmc15) dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product for similar events (complaint category keyword: damaged drive feature).Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

Event Description

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

• Brand Name: IMPLANT MOUNT 3.4MM(D) X 15MM(L)
• Type of Device: DENTAL MOUNT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 14785737
• MDR Text Key: 295319370
• Report Number: 0001038806-2022-00981
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

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 Catalogue Number: MMC15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male