MAUDE Adverse Event Report: INSTITUT STRAUMANN AG PALATAL IMPLANT Ø4.1, L 4.2MM; ENDOSSEOUS DENTAL IMPLANT

Model Number Palatal-System

Device Problem Failure to Osseointegrate (1863)

Patient Problems Fistula (1862); Pain (1994); Swelling/ Edema (4577)

Event Date 03/03/2022

Event Type  Injury  

Event Description

The clinician reports the implant was inserted (b)(6) 2022 in the patient's mouth.On (b)(6) 2022, non-osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: pain, swelling and fistula.No further patient complications were reported.

Manufacturer Narrative

The batch number could not be verified due to incomplete or missing information and / or product from the customer.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 non-integration of an endosseous dental implant during the healing phase is a known inherent risk of the treatment with dental implants.Most implant failures occur before occlusal loading (analainen et al.2013, koldsland et al.2009).Based on clinical studies about 1-3% of the implants fail within the first year after implantation (ganeles et al.2008).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 early failure rate associated with its dental implants is below the expected failure rate for this treatment as published in the scientific literature.

• Brand Name: PALATAL IMPLANT Ø4.1, L 4.2MM
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• Manufacturer (Section G): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• Manufacturer Contact: jennifer jackson ; 60 minuteman road; andover, MA 01810 ; 9787472509
• MDR Report Key: 14045881
• MDR Text Key: 294137478
• Report Number: 0009613348-2022-31243
• Device Sequence Number: 1
• Product Code: OAT
• UDI-Device Identifier: 07630031718167
• UDI-Public: 07630031718167
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K060062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Palatal-System
• Device Catalogue Number: 042.335S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/07/2022
• Event Location: Other
• Was Device Evaluated by Manufacturer?: Yes
• 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: 15 YR
• Patient Sex: Female