MAUDE Adverse Event Report: NEOBIOTECH CO. LTD.; RETRIEVAL SCREW

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported that unknown retrieval screw fractured inside of the dental implant.Implant had to be trephined out.No implant was placed and patient was sent home to heal.Tooth location # 31.Bone density type iii.

• Type of Device: RETRIEVAL SCREW
• Manufacturer (Section D): NEOBIOTECH CO. LTD.; e-space #105; 212-26 guro-dong, seoul 152-7 89; KS 152-789
• MDR Report Key: 7711418
• MDR Text Key: 114745319
• Report Number: 0001038806-2018-00690
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/20/2018,07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/01/2018
• Event Location: Other
• Date Report to Manufacturer: 07/20/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: (B)(4)
• Patient Outcome(s): Required Intervention