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 2020-02-06 for UNK - CAGE/SPACERS: SYNCAGE manufactured by Oberdorf Synthes Produktions Gmbh.
[178142791]
This report is for an unknown cage/ spacers: syncage/ unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[178142792]
This report is being filed after the review of the following journal article: dang l, sun y, wang s, pan s, li m, zhang l, & zhang f (2017), a new source of autograft bone for interbody fusion in anterior cervical discectomy and fusion surgery: experience in 893 cases, british journal of neurosurgery, volume 31, number 1, pages 33-38, (china). The purpose of this study is to share our experience of a modified anterior cervical discectomy and fusion (acdf) procedure with a new source of autograft bone for interbody fusion. Between 2008 and 2012, 893 patients who underwent anterior cervical discectomy and fusion (acdf) for cervical spine disorders, were included in the study. There were 538 males and 355 females with a mean age of 52 years (range, 25-85 years). Interbody cages and anterior cervical plates were used. After decompression, a cage with optimal height was chosen and filled with the bone collected from vertebral osteophytes and reams before being tapped into the disc space. 161 patients were implanted with and unknown synthes cervios cage, 12 patients were implanted with and unknown synthes syncage-c, 39 patients were implanted with an unknown synthes cervical spine locking plate with variable angle plate, and the rest of the patients were implanted with competitors? Devices. Neck mobilization was encouraged for all patients as soon as the drains were removed 1? 2 days after surgery. For each case, radiological fusion rate and clinical outcome were followed up for 3 and 12 months after surgery. Complications were reported as follows: (1-level fusion). 96 patients had non-fusion at 3 months follow-up. 4 patients had non-fusion at 12 months follow-up. (2-level fusion). 89 patients had non-fusion at 3 months follow-up. 12 patients had non-fusion at 12 months follow-up. (3-level fusion). 28 patients had non-fusion at 3 months follow-up. 6 patients had non-fusion at 12 months follow-up. This report is for the unknown synthes syncage-c. It captures the reported event of non-fusion. This is report 2 of 4 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-00931 |
| MDR Report Key | 9678591 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-20 |
| Date of Event | 2016-07-14 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-02-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| 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 | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL |
| Product Code | ODP |
| Date Received | 2020-02-06 |
| 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 | 2020-02-06 |