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 2020-03-26 for CRESCENT SPINAL SYSTEM 9393007INT manufactured by Msd Deggendorf Mfg.
[185034691]
This part is not approved for use in the united states; however a like device catalog #? 9393007, 510k #? K172199, udi #? (b)(4) was cleared in the united states. 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
[185034692]
Pre-operative diagnosis: adjacent segment disease procedure performed: posterior fixation was performed at l1/5 and transforaminal lumbar interbody fusion (tlif) was performed at l2/3/4. Levels implanted: l3/4 intra-op, while the cage was being placed at l3/4 the operation was stopped because the position of the marker was abnormal during rotation. It was found that the position of the marker was abnormal so the cage was suspected to be broken. As part of the fragments of the cage was retrieved from the intervertebral disc space but compression was performed so the rest fragments of the cage were left in the patient and the operation was finished. There was a less than 60 minutes delay in overall procedure time as a result of this event. There were no patient symptoms or complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00374 |
| MDR Report Key | 9881917 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-26 |
| 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 | CRESCENT SPINAL SYSTEM |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR |
| Product Code | MAX |
| Date Received | 2020-03-26 |
| Model Number | NA |
| Catalog Number | 9393007INT |
| Lot Number | UNK |
| 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 | 2020-03-26 |