FDA Adverse Event
Injury
Summary report: N
TAPERED HEX SCREW
MDR report key: 1797579
·
Received August 12, 2010
Report
- Report Number
- 2917088-2010-00008
- Event Type
- Injury
- Date Received
- August 12, 2010
- Report Date
- July 14, 2010
- Manufacturer
- ATTACHMENTS INTL., INC.
- Product Code
- EGG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
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 · 1
ON (B)(6), 2010, A DOCTOR REPORTED TO ATTACHMENTS INTERNATIONAL, INC. THAT A HEX SCREW BROKE IN A PATIENT'S MOUTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAPERED HEX SCREW | PRECISION ATTACHMENT | EGG | ATTACHMENTS INTL., INC. | 042308-20A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |