MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-09-08 for PYRAMESH 905-161 manufactured by Sofamor Danek Mfg..
[19965219]
The device was implanted on 06/09/1998. X-rays were taken due to complaints of pain. X-rays revealed that a section of the device was broken. Revision surgery was performed on 08/11/98 to remove and replace the device. It was reported that the device was broken and deformed. It is unknown at what time the fracture and deformation occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-1998-00070 |
| MDR Report Key | 186129 |
| Report Source | 07 |
| Date Received | 1998-09-08 |
| Date of Report | 1998-08-11 |
| Date of Event | 1998-08-11 |
| Date Mfgr Received | 1998-08-11 |
| Date Added to Maude | 1998-09-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PYRAMESH |
| Generic Name | MESH, METAL |
| Product Code | EZK |
| Date Received | 1998-09-08 |
| Returned To Mfg | 1998-08-11 |
| Model Number | NA |
| Catalog Number | 905-161 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 180919 |
| Manufacturer | SOFAMOR DANEK MFG. |
| Manufacturer Address | 100 PUBLISHERS DRIVE WINONA LAKE IN 46590 US |
| Baseline Brand Name | PYRAMESH |
| Baseline Generic Name | MESH, METAL |
| Baseline Model No | NA |
| Baseline Catalog No | 905-161 |
| Baseline ID | NA |
| Baseline Device Family | PYRAMESH |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K890601 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-09-08 |