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 2019-11-21 for CLYDESDALE PTC SPINAL SYSTEM 4986050 manufactured by Mdt Sofamor Danek Puerto Rico Mfg.
[167622037]
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
[167622038]
It was reported that the patient underwent oblique lumbar interbody fusion (olif) of 2 intervertebral discs and anteroposterior fixation at l3/4/5 due to lumbar spinal canal stenosis. Intra-op, during cage insertion the grasping of the cage got loose suddenly when hitting. The threaded inserter hole of the cage was stripped. It was judged that the grasping part of the inserter and the thread of the cage broke and a new cage in same size was opened to deal with it. The newly opened cage turned to a similar state, but it was inserted as it was. The intervertebral disc space was not narrow, and the surgeon cannot decide the size from 8 or 10 and the cage of 10 was inserted. There was a delay of less than 60 min in overall procedure time as a result of this event. There were no patient complications reported as the result of this event.
Patient Sequence No: 1, Text Type: D, B5
[187625273]
Product analysis results: visual inspection confirmed the threaded hole of the cage and a few of the gripping ribs have been damaged. Microscopic inspection revealed the material around the threaded hold indicates that the material may have been pulled away. This type of damage is consistent with excessive force applied to the implant during the removal process. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2019-01326 |
| MDR Report Key | 9353635 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-21 |
| Date of Report | 2019-11-21 |
| Date of Event | 2019-10-23 |
| Date Mfgr Received | 2019-10-23 |
| Device Manufacturer Date | 2019-04-15 |
| Date Added to Maude | 2019-11-21 |
| 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 | MDT SOFAMOR DANEK PUERTO RICO MFG |
| Manufacturer Street | BARRIO MARIANNA RD 909, KM0.4 |
| Manufacturer City | HUMACAO PR 00792 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00792 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLYDESDALE PTC SPINAL SYSTEM |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR |
| Product Code | MAX |
| Date Received | 2019-11-21 |
| Model Number | NA |
| Catalog Number | 4986050 |
| Lot Number | H5510808 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT SOFAMOR DANEK PUERTO RICO MFG |
| Manufacturer Address | BARRIO MARIANNA RD 909, KM0.4 HUMACAO PR 00792 US 00792 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-21 |