MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-08-07 for UNIVERSAL COMPASS HINGE 71060001 manufactured by Brooks Manufacturing Site.
[1189743]
It was reported that the hinge fractured during surgery. A second surgery was required to replace the broken device.
Patient Sequence No: 1, Text Type: D, B5
[8275321]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2009-00652 |
| MDR Report Key | 1435832 |
| Report Source | 07 |
| Date Received | 2008-08-07 |
| Date of Report | 2009-08-06 |
| Date Mfgr Received | 2009-08-05 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2009-08-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JERRY HOWARD |
| Manufacturer Street | 1450 BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996153 |
| Manufacturer G1 | BROOKS MANUFACTURING SITE |
| Manufacturer Street | 1450 BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL COMPASS HINGE |
| Generic Name | EXTERNAL FIXATION DEVICE / LYT |
| Product Code | LYT |
| Date Received | 2008-08-07 |
| Catalog Number | 71060001 |
| Lot Number | 07LM19341 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BROOKS MANUFACTURING SITE |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-08-07 |