MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-10-13 for METRX 9560565 manufactured by Warsaw Orthopedic Inc..
[18210061]
Device was returned to mfr for eval. Visual examination was conducted. Device appears to be made to print. Unable to determine the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
[18238537]
During discectomy, the tip of the micropituitary broke and was left in pt after trying to retrieve it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2004-00108 |
| MDR Report Key | 975887 |
| Report Source | 05 |
| Date Received | 2004-10-13 |
| Date of Report | 2004-09-20 |
| Date of Event | 2004-09-20 |
| Date Mfgr Received | 2004-09-20 |
| Device Manufacturer Date | 2004-06-01 |
| Date Added to Maude | 2008-01-09 |
| 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 | RICHARD TREHARNE, PH.D. |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | WARSAW ORTHOPEDIC INC. |
| Manufacturer Street | 2500 SILVEUS CROSSING |
| Manufacturer City | WARSAW IN 46852 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46852 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | METRX |
| Generic Name | MICROPITUITARY |
| Product Code | GZX |
| Date Received | 2004-10-13 |
| Returned To Mfg | 2004-09-28 |
| Model Number | NA |
| Catalog Number | 9560565 |
| Lot Number | GZ04C037 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 536194 |
| Manufacturer | WARSAW ORTHOPEDIC INC. |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46852 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-13 |