MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC DUAL-GRIP LONG FIXATION SCREW; DENTAL IMPLANT

Model Number 1000-11

Device Problem Missing Information (4053)

Patient Problem No Patient Involvement (2645)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

Indicated ni for no information available for lot #.Device manufacture date and expiration dates are unknown.This complaint was identified internally and generated for ncmr (b)(4).Per the ncmr, the part will be destroyed.

Event Description

Per complaint (b)(4), during an internal review, a part was identified as missing a label.

• Brand Name: DUAL-GRIP LONG FIXATION SCREW
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, ca ; 4443300357
• MDR Report Key: 9873306
• MDR Text Key: 184704832
• Report Number: 3001617766-2020-02952
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307108689
• UDI-Public: 10841307108689
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1000-11
• Device Catalogue Number: 1000-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Date Manufacturer Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention