MAUDE Adverse Event Report: JJGC S.A. CM DRIVE IMPL TI 3.5X16; ENDOSSEOUS DENTAL IMPLANT

Model Number	109.684
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fibrosis (3167); Hyperresponsive to stimuli (4538)
Date of Event	11/14/2022
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 fracture of a dental implant is a known long-term complication of endosseous dental implants.The manufacturers trend analysis confirms that the reported implant fracture rate associated with its dental implants is low and remains consistent with the experience as documented in the literature.There are different reasons why implants break and this problem has been illuminated by various authors (e.G.Maeglin 1988, beumer 1989, tetsch 1991, worthington 1992).Beumer and lewis 1989 report the following causes: a) production / design flaws b) inadequate fitting of the suprastructure c) occlusal overload d) bruxism e) bone resorption around the implants f) insufficient axle alignment of the implants g) trauma h) biomechanical causes i) design of the suprastructure.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2016 in ada 4.Details of surgery: implant surface not completely covered with bone and ridge augmentation.On (b)(6) 2022, fracture of the implant was verified.Patient presented with bone type iii and poor oral hygiene.The device was forwarded to the manufacturer.At the event the patient experienced: mobility and increased sensitivity.No further patient complications were reported.

• Brand Name: CM DRIVE IMPL TI 3.5X16
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• Manufacturer (Section G): JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• Manufacturer Contact: jennifer jackson ; 60 minuteman road; andover, MA 01810 ; 9787472509
• MDR Report Key: 16079225
• Report Number: 3008261720-2022-020330
• Device Sequence Number: 12327876
• Product Code: DZE
• UDI-Device Identifier: 07898237569222
• UDI-Public: 07898237569222
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• 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): 12/30/2022

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: 01/27/2020
• Device Model Number: 109.684
• Device Catalogue Number: 109.684
• Device Lot Number: 800172590I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/30/2022
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2015
• 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: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male