TAPERED HEX SCREW
Received Aug 12, 2010
Report 2917088-2010-00008 · MDR key 1797579
Device
Generic name
Precision Attachment
Manufacturer
Attachments Intl., Inc.Catalog number
73-330700
Lot number
042308-20A
Product problems
- Break
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
A DOCTOR REPORTED THAT A TAPERED HEX SCREW BROKE IN A PATIENT'S MOUTH. THE DOCTOR STATED THAT THE BREAK WAS DISCOVERED DURING A ROUTINE VISIT WHEN HE NOTICED THAT THE PATIENT'S BRIDGE WAS LOOSE. THE DOCTOR REPLACED THE BROKEN SCREW AND THE PATIENT IS DOING FINE. AN EVALUATION ON THE RETURNED SCREW CONFIRMED THAT THE SCREW HAD NO DEFECTS AND MET PRODUCT SPECIFICATIONS. THE EXACT CAUSE OF THE SCREW FRACTURE COULD NOT BE DETERMINED; HOWEVER, A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED AND NO IRREGULARITIES OR DEVIATIONS WERE FOUND. THIS IS NOT A PRODUCT FAILURE.
Description of Event or Problem
ON (B)(6), 2010, A DOCTOR REPORTED TO ATTACHMENTS INTERNATIONAL, INC. THAT A HEX SCREW BROKE IN A PATIENT'S MOUTH.