MAUDE Adverse Event Report: NOBEL BIOCARE AB - KGA ZYGOMA IMPLANT RP 50MM; ENDOSSEOUS DENTAL IMPLANT,

Catalog Number 28868

Device Problems Break (1069); Fracture (1260)

Patient Problems Fistula (1862); Inflammation (1932); No Code Available (3191)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The report was not sent to the manufacturer because the importer and manufacturer are the same company; both parties become aware of the event on the same awareness date.

Event Description

On (b)(6) 2019 a customer submitted a written complaint concerning a patient who experienced an injury.The customer stated that the patient had peri-implantitis which lead to an oroantral fistula, he will need surgery to remove the broken hardware, close the fistula, and attempt to restore his hybrid denture on 4 implants; which were supported posteriorly by his broken zygoma implant.The zygoma was sheared and broken at the head of the implant.Additional conditions involved were: significant bone loss and granulated tissue around the implant.Customer service made three attempts to obtain further information on the injury, the patient's current status, the implants cause/contribution to the injury, medical intervention required to preclude further injury, and relevant pre-existing medical conditions or medicine use.

Manufacturer Narrative

(b)(4).Complaint evaluation: the patient is a(b)(6) male, who is documented as having lekholm and zarb bone classification type iv (soft bone).The customer did not indicate the medical condition, pharmacologic implications or overall health of the patient prior to this occurrence.Conditions involved during or after implant placement include, granulated tissue around the implant site and significant bone loss.The patient had peri-implantitis that lead to oroantral fistula.Similar complaints: the affected lot was manufactured on june 16, 2015.No other similar complaints were received for this lot.Cause analysis: nobel biocare cannot provide a final conclusion as to the cause or contribution of material number 28868 to this fistula or implant fracture occurrence due to lack of background information.Visual inspection identified surface scratches, a propagated crack, and deformation marks in the hex head that could have been created during the removal surgery.No obvious damage was observed in the abutment screw channel.Device history review: a dhr request was performed on november 29, 2019 showing no deviations.The retain sample complies with specification.The implant stayed unloaded during the first year.No information was provided on the bone quality or quantity when loading, components (e.G.Screws, abutments, etc.); or mechanical configurations/3d panorama x-ray (i.E.Cantilever length, implants angulation, bone support).This failure mode could be compatible with dynamic fatigue fracture.Other causes or contributors to implant fracture over a certain period of time may be mechanical overload or exceeding the limits of components.Risk analysis: 1.Risks associated with zygoma implant surgery include: life threatening hemorrhage, infection of the maxillary sinus, insufficient bone volume, fistula occurrences, failure to integrate, loss of integration, local and systemic infections, bone loss or resorption, periodontal inflammation, soft tissue resorption.Damage to vital anatomical structures.2.Mechanical forces: a.Excessive insertion torque can result in distortion or fracture of the implant, failure of the implant to integrate, and bone loss.B.Excessive mastication forces can lead to failure to integrate, loss of integration, bone loss or fracture of the implant 3.Inability to maintain hygienic safety: a.Inability of the clinician to eliminate contaminants and sources of infection could result in possible local infection, fistula, failure of the implant to integrate and bone loss.B.Inability of the patient to maintain hygiene can result in periodontal inflammation and in extreme cases loss of integration and bone loss.Control measures: 1.The ifus give information on how to use the devices and provides cautions and warnings in line with the associated risks.Several cautions and warnings are provided, informing the user about typical aspects to be aware of and also typical adverse events.Especially, the user is informed about sinusitis and fistulas, which are seldom but typical adverse events occurring when using zygoma implants.2.Mechanical forces: the implants have been validated for insertion torque and fatigue strength and exceed the requirements for implant strength, see design reports.3.Inability to maintain hygienic safety a.Clinicians are advised to eliminate contaminants and sources of infection in the general ifu 10148.B.Patients are instructed by the clinician on proper oral hygiene.Improper care is detectable at regular follow appointments conclusion: investigation of this complaint file will be closed based on current available information and will be re-opened should additional information become available or the product be returned.No control measures are deemed necessary.

Event Description

On (b)(6) 2019 a customer submitted a written complaint concerning a patient who experienced an injury.The customer stated that the patient had peri-implantitis which lead to an oroantral fistula, he will need surgery to remove the broken hardware, close the fistula, and attempt to restore his hybrid denture on 4 implants; which were supported posteriorly by his broken zygoma implant.The zygoma was sheared and broken at the head of the implant.Additional conditions involved were: significant bone loss and granulated tissue around the implant.Customer service made three attempts to obtain further information on the injury, the patient's current status, the implants cause/contribution to the injury, medical intervention required to preclude further injury, and relevant pre-existing medical conditions or medicine use.

• Brand Name: ZYGOMA IMPLANT RP 50MM
• Type of Device: ENDOSSEOUS DENTAL IMPLANT,
• Manufacturer (Section D): NOBEL BIOCARE AB - KGA; dimbovgen 2; karlskoga, SE-69 1 5; SW SE-69 1 51
• MDR Report Key: 9465356
• MDR Text Key: 170648812
• Report Number: 2027971-2019-26864
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 7332747025224
• UDI-Public: (01)7332747025224(10)12044245(17)200514
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 12/13/2019,11/18/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2020
• Device Catalogue Number: 28868
• Device Lot Number: 12044245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2019
• Distributor Facility Aware Date: 11/18/2019
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR