MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2019-09-06 for PROBE 8350294 manufactured by Medtronic Sofamor Danek Usa, Inc.
[156816919]
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[156816920]
It was reported that during thoraco-lumbar fusion surgery, the probe broke by an inch while the surgeon was fighting a very sclerotic bone. No fragment of the broken probe remained inside the patient. No more information is available yet.
Patient Sequence No: 1, Text Type: D, B5
[165317516]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[165317517]
The broken probe was replaced with another one to complete the procedure. No patient complications were reported due to this event.
Patient Sequence No: 1, Text Type: D, B5
[176343146]
Product analysis: visual and optical inspection confirmed the probe was returned with approximately 38mm of the tip broken off. The broken off portion of the shaft was not returned for evaluation. The angle on the face of the fracture surface is consistent with bend stress overload. The material hardness of the probe shaft was checked and meets print specification. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2019-00995 |
| MDR Report Key | 8971628 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2019-09-06 |
| Date of Report | 2019-11-06 |
| Date of Event | 2019-07-29 |
| Date Mfgr Received | 2019-10-21 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2019-09-06 |
| 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 | 2019-09-06 |
| Model Number | NA |
| Catalog Number | 8350294 |
| Lot Number | SW10J044 |
| 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 | 2019-09-06 |