MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELSPEEDY SHORTY NP Ø3.3MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	37609
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
Implant failed due to an osseointegration problem.

• Brand Name: NOBELSPEEDY SHORTY NP Ø3.3MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovgen 2; karlskoga, SE-69 151; SW SE-69151
• MDR Report Key: 9606087
• Report Number: 9611993-2020-02492
• Device Sequence Number: 2738681
• Product Code: DZE
• UDI-Device Identifier: 07332747086287
• UDI-Public: (01)07332747086287(10)12023860(17)190601
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K050406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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: 06/01/2019
• Device Model Number: 37609
• Device Catalogue Number: 37609
• Device Lot Number: 12023860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 01/20/2020
• 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