MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) UNKNOWN BONE CONDENSOR; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

Because a serious injury resulted, this event is reportable per 21 cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Event Description

A (b)(6) male patient received one astra tech implant osseospeed tx 3,5x9 (ref 24931) on (b)(6) 2017 in region 5 (fdi # 14).The implant was lost for unknown reasons on (b)(6) 2018.At the same date the customer decided to place one osseospeed tx implant 4,0x 9 (ref 24941), but during implant bed preparation with bone condensor (no ref or product name available) the bone lamellae fractured and the implant was not stable and was explanted.

• Brand Name: UNKNOWN BONE CONDENSOR
• Type of Device: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal, S-431 21; SW S-431 21
• Manufacturer (Section G): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal, S-431 21; SW S-431 21
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 7848386
• MDR Text Key: 119283994
• Report Number: 9612468-2018-00001
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention