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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC DUAL-GRIP LONG FIXATION SCREW; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC DUAL-GRIP LONG FIXATION SCREW; DENTAL IMPLANT Back to Search Results
Model Number 1000-11
Medical Device Problem Code Missing Information (4053)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 08/16/2019
Type of Reportable Event Malfunction
Additional 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 or Problem Description
Per complaint (b)(4), during an internal review, a part was identified as missing a label.
 
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Brand Name
DUAL-GRIP LONG FIXATION SCREW
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks, ca
MDR Report Key9873306
Report Number3001617766-2020-02952
Device Sequence Number13593435
Product Code NHA
UDI-Device Identifier10841307108689
UDI-Public10841307108689
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K061319
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 03/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number1000-11
Device Catalogue Number1000-11
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/16/2019
Initial Report FDA Received Date03/24/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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