MAUDE Adverse Event Report: BICON, LLC INTEGRA-CP; DENTAL IMPLANT

Catalog Number	260-350-306
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Account reported the following: extraction 12 weeks prior, no bone graft, antibiotics given for 7 days post-op, significant torri and clenching, mobile since last cleaning 4 months ago, no resolution with debridement and antibiotics, no radiographis prior to october.
Event or Problem Description
According to dentist, the patient came in for cleaning at implant #30; had class 3 mobility but no occlusal contacts.Reported implant is failing requiring removal and replacement.

• Brand Name: INTEGRA-CP
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BICON, LLC; 501 arborway; boston MA 02130
• Manufacturer (Section G): BICON, LLC; 501 arborway; boston MA 02130
• Manufacturer Contact: richard wu ; 501 arborway; boston, MA 02130 ; 6175244443
• MDR Report Key: 19053479
• Report Number: 1223843-2024-00002
• Device Sequence Number: 7069538
• Product Code: DZE
• UDI-Device Identifier: 00813110022837
• UDI-Public: (01)00813110022837(17)280630(10)200070523B
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K042637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 260-350-306
• Device Lot Number: 200070523B
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male