MAUDE Adverse Event Report: NEOBIOTECH FIXTURE REMOVER SCREW M 2.0; IMPLANT REMOVAL SCREW

Catalog Number FRS20

Device Problems Fracture (1260); Sticking (1597)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 08/09/2016

Event Type  Injury  

Event Description

The dentist reported that during the procedure to remove an unknown implant the fixture remover screw (frs20) fractured and stuck inside the fixture remover (fr415).The dentist completed the removal of the implant surgically.

Event Description

The dentist reported that during the procedure to remove a non-zimmer biomet implant the fixture remover screw (frs20) fractured and broke off inside the implant.The fractured portion of the remover screw became stuck in the fixture remover (fr415).The dentist completed the removal of the implant surgically.

• Brand Name: FIXTURE REMOVER SCREW M 2.0
• Type of Device: IMPLANT REMOVAL SCREW
• Manufacturer (Section D): NEOBIOTECH; e-space # 1010, 212-26; guro-dong, guro-gu, seoul FL ; KS
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 5906114
• MDR Text Key: 53093780
• Report Number: 0001038806-2016-00216
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 08/26/2016,08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: FRS20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2016
• Distributor Facility Aware Date: 08/09/2016
• Event Location: Other
• Date Report to Manufacturer: 09/21/2016
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention