MAUDE Adverse Event Report: INSTITUT STRAUMANN AG CIM 4.1MM RD, ZLA 14MM, AH5.5MM, ZRO2; ENDOSSEOUS DENTAL IMPLANT

Model Number	Ceramic TL
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Pain (1994); Fibrosis (3167); Hyperresponsive to stimuli (4538); Swelling/ Edema (4577)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The batch number could be verified.Our manufacturing q-system assures, that production and process controls are in place to ensure that batches confirm to the applicable specifications before they are distributed.  the loss of an endosseous dental implant after successful osseointegration and restoration is a known inherent risk of the procedure.Implants may have to be removed in case one or more of the implant success criteria are not met.Implant success criteria according to buser et al.(1991) are: absence of persistent subjective complaints such as pain, foreign body sensation and /or dysesthesia.Absence of a recurrent peri-implant infection with suppuration.Absence of implant mobility.Absence of a continuous radiolucency around the implant.The manufacturer's trend analysis confirms that the reported failure rate associated with its dental implants is below the expected failure rate for this treatment as published in the scientific literature.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2020 in ada 6.Details of surgery: ridge augmentation.On (b)(6) 2021, loss of osseointegration was verified.Patient presented with bone type iii and previous bone augmentation.The device was forwarded to the manufacturer.At the event the patient experienced: pain, mobility, swelling, bleeding, increased sensitivity and inflammation.No further patient complications were reported.

• Brand Name: CIM 4.1MM RD, ZLA 14MM, AH5.5MM, ZRO2
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• MDR Report Key: 12563785
• Report Number: 0009613348-2021-74281
• Device Sequence Number: 13803458
• Product Code: DZE
• UDI-Device Identifier: 07630031714015
• UDI-Public: 07630031714015
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/01/2021

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 Expiration Date: 03/22/2024
• Device Model Number: Ceramic TL
• Device Catalogue Number: 031.034S
• Device Lot Number: VW446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/01/2021
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR