MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-10-07 for METRX EX0513120 manufactured by Medtronic Sofamor Danek Usa, Inc.
[3752907]
It was reported that the tip of the curette broke off in the patient disc space during a discectomy. The disc space collapsed. The tip of the currette was left in the disc space.
Patient Sequence No: 1, Text Type: D, B5
[11224478]
(b)(6). (b)(4). Location : hospital. The device has been returned to the manufacturer for evaluation. Macroscopic examination confirms ~5mm of probe tip broken off, the broken off portion of the tip is missing and not returned for analysis. Microscopic examination of the fracture revealed a quasi-brittle fracture surface with no indications of torsion or fatigue. Plastic deformation of tip suggests the direction of fracture, consistent with bend stress overload. Tip diameter and material hardness inspected and found to be conforming to print specification. The above observations are consistent with bend stress overload.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2013-04091 |
| MDR Report Key | 3391092 |
| Report Source | 05 |
| Date Received | 2013-10-07 |
| Date of Report | 2013-09-11 |
| Date of Event | 2013-09-11 |
| Date Mfgr Received | 2013-09-11 |
| Device Manufacturer Date | 2013-08-22 |
| Date Added to Maude | 2013-10-07 |
| 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 | HUZEFA MAMOOLA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | METRX |
| Generic Name | CURETTE |
| Product Code | HTF |
| Date Received | 2013-10-07 |
| Returned To Mfg | 2013-10-02 |
| Model Number | NA |
| Catalog Number | EX0513120 |
| Lot Number | TI13H045 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-07 |