MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-06-04 for ULTRATINE FOREHEAD 3.0 23201 manufactured by Coapt Systems, Inc.
[22049167]
The explanted material has been returned to the mfr, however, an evaluation to determine failure mode has not yet been conducted. The batch record for this lot has been reviewed and contains no abnormal manufacturing events. The complaint rate for this device is very low. If additional info becomes available, it will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[22099108]
In 2008, the physician implanted two devices. The pt contacted the physician six months after the procedure claiming that the devices were still present and have not dissolved. The physician suggested that no action should be taken at that point and recommended that they wait a few more months. Nine months after the procedure, the devices were still visible. The devices were explanted in 2009.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003644133-2009-00016 |
| MDR Report Key | 1399642 |
| Report Source | 05 |
| Date Received | 2009-06-04 |
| Date of Report | 2009-05-04 |
| Date of Event | 2009-05-04 |
| Date Mfgr Received | 2009-05-04 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2009-06-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LINDA RUEDY, DIR |
| Manufacturer Street | 1820 EMBARCADERO RD |
| Manufacturer City | PALO ALTO CA 94303 |
| Manufacturer Country | US |
| Manufacturer Postal | 94303 |
| Manufacturer Phone | 6504617600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRATINE FOREHEAD 3.0 |
| Generic Name | SMOOTH METALLIC BONE FIXATION FASTENER |
| Product Code | NDL |
| Date Received | 2009-06-04 |
| Returned To Mfg | 2009-05-06 |
| Model Number | 23201 |
| Catalog Number | 23201 |
| Lot Number | 02092 |
| Device Expiration Date | 2010-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COAPT SYSTEMS, INC |
| Manufacturer Address | PALO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-06-04 |