MAUDE Adverse Event Report: NEODENT - JJGC S.A. GM HELIX ACQUA IMPLANT 3.75X8; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.976
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Tissue Damage (2104)
Date of Event	05/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number reported by the dentist was not verified by the system, so it was not considered.The information provided in this report was based on information given by the dentist in neodent¿s products warranty form.The original complaint was received by the subsidiary and did not arrive in the manufacturer yet.When this happens, a new evaluation of the complaint will be carried out and, if necessary, a follow-up report will be send.
Event or Problem Description
(b)(4) - the dentist reported that 2 months and 14 days after the dental implant was installed in intraoral region 20#, its non- osseointegration was observed.Moreover, immediate implant was done and immediate load procedure was performed.
Event or Problem Description
(b)(4) - the dentist reported that 2 months and 14 days after the dental implant was installed in intraoral region 20#, its non- osseointegration was observed.Moreover, immediate implant was done and immediate load procedure was performed.
Additional Manufacturer Narrative
Follow-up is being sent to correct information sent in field catalog number and lot number.The complaint was received by manufacturer and, after analysis, new informations were obtained.A follow-up is being sent to correct these informations according to the evaluation made.The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form, visual conference of the product returned by the dentist and the evaluation of relevant production records.

• Brand Name: GM HELIX ACQUA IMPLANT 3.75X8
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NEODENT - JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• MDR Report Key: 8855029
• Report Number: 3008261720-2019-03906
• Device Sequence Number: 14010713
• Product Code: DZE
• UDI-Device Identifier: 07899878024651
• UDI-Public: 07899878024651
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K163194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2019
• Report Date (Section F): 07/10/2019

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: 01/23/2021
• Device Catalogue Number: 140.976
• Device Lot Number: TZ234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/22/2019
• Event Location: Other
• Date Report to Manufacturer: 07/10/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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