MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-02 for PROBE 25000300 manufactured by Medtronic Sofamor Danek Usa, Inc.
[164831564]
Device fragment in patient. Radiological images review result:. Intra-op images of ilium instrumention were provided. Ap angle images show metallic fragment is present across the sacroiliac joint line. Without corresponding lateral view, it is difficult to know if this has returned in pelvis as it is at different trajectory than the instrumentation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[164831565]
It was reported that intra-op, tip of the probe broke off and remained in the si joint of the patient. No patient complications have been reported as a result of this event yet.
Patient Sequence No: 1, Text Type: D, B5
[167723927]
X-ray review results: intra-op images for ilium instrumentation were provided. Ap angle shows a metallic fragment present across the sacroiliac joint line. Without corresponding lateral views, it is difficult to know if this is placed in the pelvis as it is at a different trajectory than the instrumentation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[173251635]
Product analysis: visual observation reveals that the tip of the probe has been broken/sheared off and is missing from what appears to be overload. Hardness reveals that the probes are the proper hardness. This is consistent with bend stress overload. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2019-01259 |
| MDR Report Key | 9270315 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-02 |
| Date of Report | 2019-11-22 |
| Date of Event | 2019-10-04 |
| Date Mfgr Received | 2019-10-23 |
| Date Added to Maude | 2019-11-02 |
| 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 | 3 |
| Manufacturer Contact | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBE |
| Generic Name | PROBE |
| Product Code | HXB |
| Date Received | 2019-11-02 |
| Model Number | NA |
| Catalog Number | 25000300 |
| Lot Number | CT16A015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-11-02 |