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 2020-03-10 for CLYDESDALE SPINAL SYSTEM 2926250 manufactured by Msd Deggendorf Mfg.
[183295350]
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
[183295351]
It was reported that the patient presented with lumbalgia at l3-l4 and l4-l5; and underwent oblique lumbar interbody fusion at l2-l3 and l3-l4. Intra-op, the cage broke. No fragment of the broken cage remained inside the patient. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00295 |
| MDR Report Key | 9811904 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-09-12 |
| Date Added to Maude | 2020-03-10 |
| 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 | MSD DEGGENDORF MFG |
| Manufacturer Street | WERTSTRASSE 17 |
| Manufacturer City | DEGGENDORF 94469 |
| Manufacturer Country | DE |
| Manufacturer Postal Code | 94469 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLYDESDALE SPINAL SYSTEM |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR |
| Product Code | MAX |
| Date Received | 2020-03-10 |
| Model Number | NA |
| Catalog Number | 2926250 |
| Lot Number | 35JE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MSD DEGGENDORF MFG |
| Manufacturer Address | WERTSTRASSE 17 DEGGENDORF 94469 DE 94469 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |