MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-05 for CAPSTONE SPINAL SYSTEM 2990001 manufactured by Medtronic Sofamor Danek Usa, Inc.
[165227487]
Neither the devices nor the product was not 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
[165227488]
It was reported that the patient underwent posterior lumbar interbody fusion due to lumbar canal stenosis. Intra-operatively, the tip of the inserter was found to be broken off when the inserter was removed after placing the cage at l5/s. The broken tip was found in the operative field when the reported inserter was removed. There were no patient complications as a result of alleged event. There was a delay of less than 60 mins in procedure time as a result of alleged event. The patient issue was resolved.
Patient Sequence No: 1, Text Type: D, B5
[187449796]
Product analysis results: visual and optical examination of the returned instrument confirmed one of the tangs at the tip of the inserter has been broken off. The fracture surface is relatively flat and brittle. This type of damage 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 | 1030489-2019-01272 |
| MDR Report Key | 9278061 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-05 |
| Date of Report | 2019-11-05 |
| Date of Event | 2019-10-07 |
| Date Mfgr Received | 2019-10-07 |
| Device Manufacturer Date | 2014-02-03 |
| Date Added to Maude | 2019-11-05 |
| 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 | CAPSTONE SPINAL SYSTEM |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| Date Received | 2019-11-05 |
| Model Number | NA |
| Catalog Number | 2990001 |
| Lot Number | NM12F025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-11-05 |