MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-01-30 for UNK - CAGE/SPACERS: SYNCAGE manufactured by Oberdorf Synthes Produktions Gmbh.
[187102582]
(b)(4). Additional pro-code: ove. 510k: this report is for an unknown cage/spacers: syncage/unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. Investigation summary product was not returned. Based on the information available, it has been determined that no corrective and preventive action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[187102643]
This report is being filed after the review of the following journal article: wei, l. Et al. (2019), comparison of three anterior techniques in the surgical treatment of three-level cervical spondylotic myelopathy with intramedullary t2-weighted increased signal intensity, world neurosurgery, vol. 126, pages e824-e852 (china). The objective of this study is to compare the clinical and radiologic outcomes of 3 anterior surgical techniques for the treatment of 3-level cervical spondylotic myelopathy (csm) and the evolution of intramedullary t2-weighted increased signal intensity (isi). From january 2006 to january 2016, a total of 38 patients (26 males and 12 females) with an average age of 53. 52-60. 64 underwent anterior cervical discectomy and fusion using a syncage; synthes, mezzovico-vira, switzerland. The following complications were reported as follows: a (b)(6) male patient's postoperative lateral radiograph and sagittal t2-weighted mri in the final follow-up showed good position of instrumentation and markable regression of increased signal intensity on t2-weighted mri. The intervertebral height between c5 and c6 is relatively narrow, which is not suitable for acdf at c5ec6 level. In addition, the brightest area of isi is located behind the c5 vertebral body. Performing c5 corpectomy is expected to achieve a better decompression and re-expansion of cervical spinal cord. In the postoperative mri, the isi behind the c4 vertebrae is resolved completely, but isi behind the c5 vertebrae is still existed. In this case, it is optimal to perform c5 corpectomy to achieve a better regression of isi. 2 patients suffered cerebral fluid leakage. This report is for a syncage; synthes, (b)(4). This impacted product captures the reported (b)(6) male patient who isi behind the c5 vertebrae that still existed. This report is for one (1) unk - cage/spacers: syncage this report is 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-00734 |
| MDR Report Key | 9649653 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-09 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-01-30 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK - CAGE/SPACERS: SYNCAGE |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| Date Received | 2020-01-30 |
| Catalog Number | UNK - CAGE/SPACERS: SYNCAGE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-30 |