MAUDE Adverse Event Report: ZEST ANCHORS, LLC LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI); ENDOSSEOUS DENTAL IMPLANT

Model Number	07460-S
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Non-integration.Dr (b)(6) called in (b)(6) 2023 that his lodi implants did not have osseo-integration on one pt.Dr placed 6 lodis on jan 25th, they started failing 3 weeks later and by (b)(6) they were all out.Dr did not have reference numbers or lot numbers.He provided me implant specs and i am inputting my educated guess on ref and lot numbers in the notes section below.
Additional Manufacturer Narrative
Clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.The event of sinus infection deemed not device related is considered an unexpected adverse drug experience.
Event or Problem Description
Non-integration.Doctor (b)(6) called in (b)(6) 2023 that his lodi implants did not have osseo-integration on one patient.Doctor placed 6 lodis on (b)(6), they started failing 3 weeks later and by (b)(6) they were all out.Dr did not have reference numbers or lot numbers.He provided me implant specs and i am inputting my educated guess on ref and lot numbers in the notes section below.

• Brand Name: LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): ZEST ANCHORS, LLC; 2875 loker ave east; carlsbad 92010
• Manufacturer (Section G): ZEST ANCHORS, LLC; 2875 loker ave east; carlsbad 92010
• Manufacturer Contact: amie toor ; 2875 loker ave e; carlsbad, CA 92010
• MDR Report Key: 16773191
• Report Number: 2023950-2023-00123
• Device Sequence Number: 20427570
• Product Code: DZE
• UDI-Device Identifier: 00840481131165
• UDI-Public: 00840481131165
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K120198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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 Model Number: 07460-S
• Device Catalogue Number: N/A
• Device Lot Number: L1W2G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (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: Hospitalization; Congenital Anomaly
• Patient Sex: Unknown