MAUDE Adverse Event Report: JJGC S.A. SELF-DRILLING ANCHORAGE IMPL LB TI 1.3X9; ENDOSSEOUS DENTAL IMPLANT

Model Number 109.485

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  Injury  

Event Description

The clinician reports the implant was inserted (b)(6) 2022 in the patient's mouth.On (b)(6) 2022, fracture of the implant was verified.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications reported.

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: production / design flaws, inadequate fitting of the suprastructure, occlusal overload, bruxism, bone resorption around the implants, insufficient axle alignment of the implants, trauma, biomechanical causes, and design of the suprastructure.

• Brand Name: SELF-DRILLING ANCHORAGE IMPL LB TI 1.3X9
• Type of Device: 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: 14412537
• MDR Text Key: 291977200
• Report Number: 3008261720-2022-05873
• Device Sequence Number: 1
• Product Code: OAT
• UDI-Device Identifier: 07898237567518
• UDI-Public: 07898237567518
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K102769
• 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: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 109.485
• Device Catalogue Number: 109.485
• Device Lot Number: JEZ82
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/16/2022
• Event Location: Other
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2021
• 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: 46 YR
• Patient Sex: Male