MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-06-18 for ULTRATINE FOREHEAD 3.0 23201 manufactured by Coapt Systems, Inc..
[18107223]
In 2009, the physician implanted the devices with no complications. Six days later, the patient returned for a scheduled post-op visit. The physician noted that the right side of the brow was lower than the left. The device was explanted two months later.
Patient Sequence No: 1, Text Type: D, B5
[18351888]
The explanted device was returned to the manufacturer and was evaluated by r&d. The investigation determined that one of the two flanges on the post of the device was crushed. This mechanism of failure has been identified as "off-center alignment of the device over the drilled hole". This results in an insecure fit in the drilled hole causing the device to become dislodged. The batch record for this lot has been reviewed, which contains no abnormal manufacturing events. The complaint rate for this lot is not considered abnormal for this device. If additional information becomes available, it will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003644133-2009-00018 |
| MDR Report Key | 1405893 |
| Report Source | 05 |
| Date Received | 2009-06-18 |
| Date of Report | 2009-05-19 |
| Date of Event | 2009-05-18 |
| Date Mfgr Received | 2009-05-19 |
| Device Manufacturer Date | 2008-09-01 |
| Date Added to Maude | 2009-06-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA RUEDY, DIRECTOR |
| 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 | 2009-06-18 |
| Returned To Mfg | 2009-06-01 |
| Model Number | 23201 |
| Catalog Number | 23201 |
| Lot Number | 02251 |
| Device Expiration Date | 2010-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2009-06-18 |