MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-08-12 for TAPERED HEX SCREW 73-330700 manufactured by Attachments Intl., Inc..
[21324674]
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.
Patient Sequence No: 1, Text Type: N, H10
[21428587]
On (b)(6), 2010, a doctor reported to attachments international, inc. That a hex screw broke in a patient's mouth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2917088-2010-00008 |
| MDR Report Key | 1797579 |
| Report Source | 08 |
| Date Received | 2010-08-12 |
| Date of Report | 2010-07-14 |
| Date Mfgr Received | 2010-07-14 |
| Date Added to Maude | 2010-08-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| Manufacturer G1 | ATTACHMENTS INTL., INC. |
| Manufacturer Street | 824 COWAN ROAD |
| Manufacturer City | BURLINGAME 94010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAPERED HEX SCREW |
| Generic Name | PRECISION ATTACHMENT |
| Product Code | EGG |
| Date Received | 2010-08-12 |
| Catalog Number | 73-330700 |
| Lot Number | 042308-20A |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATTACHMENTS INTL., INC. |
| Manufacturer Address | 824 COWAN ROAD BURLINGAME 94010 US 94010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-08-12 |