MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-09-30 for STABLEDENT SNAP CAP PR3128 manufactured by Folsom Metal Products, Inc..
[1247414]
On (b)(6) 2008, dr (b)(6) phoned in a complaint to our firm ((b)(4)) stating that two implant snap caps in the lower mandible had worn out and lost retention after four (4) weeks. He had replaced the snap caps that had worn, however, the new ones wore out again this time only after two (2) weeks. He was concerned as to why this was happening, and wanted to see what type of intervention needed to take place to prevent the patient from experiencing any adverse events.
Patient Sequence No: 1, Text Type: D, B5
[8418345]
Manufacturer did not necessarily feel this was an adverse event. However, all capa procedures were completed to verify the patient safety.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1065595-2009-10004 |
| MDR Report Key | 1507555 |
| Report Source | 05,07 |
| Date Received | 2009-09-30 |
| Date of Report | 2008-06-21 |
| Date of Event | 2008-06-19 |
| Date Mfgr Received | 2008-06-21 |
| Device Manufacturer Date | 2006-02-15 |
| Date Added to Maude | 2010-09-08 |
| 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 | AUBREY FOLSOM |
| Manufacturer Street | 153 CAHABA VALLEY PKWY. |
| Manufacturer City | PELHAM AL 35124 |
| Manufacturer Country | US |
| Manufacturer Postal | 35124 |
| Manufacturer Phone | 2057330901 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STABLEDENT SNAP CAP |
| Generic Name | GCZ- RETAINER |
| Product Code | GCZ |
| Date Received | 2009-09-30 |
| Returned To Mfg | 2008-06-21 |
| Catalog Number | PR3128 |
| Lot Number | I02201 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOLSOM METAL PRODUCTS, INC. |
| Manufacturer Address | PELHAM AL 35124 US 35124 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-09-30 |