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

Catalog Number	260-360-305
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Hypoesthesia (2352); Tactile Disorders (4419)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the only information from the account at this time: post implant hypoesthesia and dysesthesia.The information is likely pertaining to the patient's tooth #19 area.
Additional Manufacturer Narrative
According to the account on 1/12/24, the patient is recovering.The site was a healed site when the implant was placed, but it was close to the inferior alveolar nerve (ian).They stated they thought that the hypoesthesia and dysesthesia was caused by the implant being placed too deep.The issues reported would not be caused by the implant device itself; some other factor would have caused the symptoms the patient is experiencing.
Event or Problem Description
According to the only information from the account at this time: post implant hypoesthesia and dysesthesia.Tthe information is likely pertaining to the patient's tooth #19 area.

• 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: 18510377
• Report Number: 1223843-2024-00001
• Device Sequence Number: 3533844
• Product Code: DZE
• UDI-Device Identifier: 00813110023056
• UDI-Public: (01)00813110023056(17)280331(10)192020323B
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K073368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: 260-360-305
• Device Lot Number: 192020323B
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• 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; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female