MAUDE Adverse Event Report: ZIMMER DENTAL ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 3.15MM(D) X 10MM(L); DENTAL IMPLANT

Catalog Number ACT3110

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Osteolysis (2377)

Event Date 06/06/2022

Event Type  Injury  

Manufacturer Narrative

Multiple mdr reports were filed for this event.Please see associated report: 0002023141-2022-01597.Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Lot number unknown / not provided.A summary investigation has been completed for bone loss and infection events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for bone loss and infection have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss and escaping the available detections has been assessed and found remote and almost non-existent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.

Event Description

Customer reported loss of bone with infection and buccal at tooth locations #20 and #21.Symptoms as a result of the event: pain, inflammation.

• Brand Name: ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 3.15MM(D) X 10MM(L)
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 14789037
• MDR Text Key: 294950783
• Report Number: 0002023141-2022-01599
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ACT3110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female