MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELSPEEDY SHORTY NP 3.3MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	37609
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
Implant failed due to a failure to osseointegrate.

• Brand Name: NOBELSPEEDY SHORTY NP 3.3MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovgen 2; karlskoga, SE-69 151; SW SE-69151
• MDR Report Key: 9761273
• Report Number: 9611993-2020-10080
• Device Sequence Number: 559627
• Product Code: DZE
• UDI-Device Identifier: 07332747086287
• UDI-Public: (01)07332747086287(10)12047319(17)200723
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K050406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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: 07/23/2020
• Device Model Number: 37609
• Device Catalogue Number: 37609
• Device Lot Number: 12047319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/27/2020
• 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
• Patient Age: 39 YR