MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-04-24 for ULTRALINE FOREHEAD 3.0 23201 manufactured by Coapt Systems, Inc..
[16112101]
The physician implanted two devices in 2009. On the following month, the physician re-operated to remove both devices, because they broke postoperatively. Replacement devices were also implanted during the second surgery.
Patient Sequence No: 1, Text Type: D, B5
[16159867]
The explanted devices have been returned to the manufacturer. An internal investigation is in process. The batch record for this lot has been reviewed, which contains no abnormal manufacturing events. There is a low occurrence of device breakage postoperatively. If additional information becomes available, it will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003644133-2009-00010 |
| MDR Report Key | 1370504 |
| Report Source | 05 |
| Date Received | 2009-04-24 |
| Date of Report | 2009-03-27 |
| Date of Event | 2009-03-18 |
| Date Mfgr Received | 2009-03-27 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2009-05-04 |
| 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 | ULTRALINE FOREHEAD 3.0 |
| Generic Name | SMOOTH METALLIC BONE FIXATION FASTENER |
| Product Code | NDL |
| Date Received | 2009-04-24 |
| Returned To Mfg | 2009-03-31 |
| Model Number | 23201 |
| Catalog Number | 23201 |
| Lot Number | 01847 |
| Device Expiration Date | 2009-07-31 |
| 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 | 2009-04-24 |