MAUDE Adverse Event Report: DENTAURUM GMBH & CO. KG TOMAS PIN SD 08; IMPLANT, ENDOSSEOUS, ORTHODONTIC

Model Number 302-108-00

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2023

Event Type  malfunction  

Event Description

The tip of temporary anchorage device broke as it was inserted into the jawbone.The tip broke off at approximately 6mm insertion depth.The first incident occurred on (b)(6) 2023 and the second on (b)(6) 2023.Both incidents occurred on the same patient.Reference report: mw5118104.

• Brand Name: TOMAS PIN SD 08
• Type of Device: IMPLANT, ENDOSSEOUS, ORTHODONTIC
• Manufacturer (Section D): DENTAURUM GMBH & CO. KG
• MDR Report Key: 17057622
• MDR Text Key: 316625540
• Report Number: MW5118105
• Device Sequence Number: 1
• Product Code: OAT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 302-108-00
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female