MAUDE Adverse Event Report: INSTITUT STRAUMANN AG CIM Ø4.1MM RD, ZLA 14MM, AH5.5MM, ZRO2; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	031.034S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Abscess (1690); Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Pain (1994); Swelling (2091)
Date of Event	08/30/2019
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 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 disesthesia.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.
Event or Problem Description
The clinician reported that two weeks after the dental implant was placed, in ada site #8 of the patient's mouth, non-osseointegration was observed.The patient presented type iv bone.The device was returned to the manufacturer for investigation.Patient experienced pain, bleeding, swelling, inflammation and abscess at time of event, no further complications were observed.

• Brand Name: CIM Ø4.1MM RD, ZLA 14MM, AH5.5MM, ZRO2
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel, CH-40 02; SZ CH-4002
• MDR Report Key: 9189043
• Report Number: 1222315-2019-09790
• Device Sequence Number: 11733684
• Product Code: DZE
• UDI-Device Identifier: 07630031714015
• UDI-Public: 07630031714015
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/07/2019

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: 07/05/2023
• Device Catalogue Number: 031.034S
• Device Lot Number: RH924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/14/2019
• 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: 48 YR