MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-02-12 for UNKNOWN CAGE/SPACER manufactured by Medos International Sàrl Ch.
[186020530]
This report is for an unknown cage/spacer /unknown lot. Part and lot numbers are unknown; udi number is unknown. Implant date unknown. 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 product was received; no conclusion could be drawn at the time of filing this report. 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.
Patient Sequence No: 1, Text Type: N, H10
[186020531]
Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal abstract: heider f. C. , mayer f. , mehren c. , mayer h. M. (2018), 3-d printed cellular titanium cervical implants enriched with autologous bone marrow leads to a fast, early and solid bony fusion at the cervical spine: a prospective comparison trial with >= 1-year follow-up, european spine journal, volume 27, page 2948, (germany). This study aims to compare the clinical and radiological outcomes of 3-d printed cellular titanium cages enriched with autologous bone marrow with peek cages filled with autograft. A total of 44 patients (overall 61 eit cages) who were treated with an unknown depuy eit cellular titanium cervical cage were included in the study. The clinical and radiological outcome of 3-d printed cellular titanium cages enriched with autologous bone marrow was compared to with unknown peek cages filled with autograft. Out of these patients, 41 patients were available for 3 months follow-up, 38 patients for 6 months, and 37 patients for 12 months. Heider f. C. , mayer f. , mehren c. , mayer h. M. (2018)/3-d printed cellular titanium cervical implants enriched with autologous bone marrow leads to a fast, early and solid bony fusion at the cervical spine: a prospective comparison trial with >= 1-year follow-up complications were reported as follows: unknown patients had subsidence. Depuy spine product: unknown depuy spine eit cellular titanium cervicel cage. This is report 01 of 01 of (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00526 |
| MDR Report Key | 9701602 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-02-12 |
| Date of Report | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-12 |
| 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 | CHEMIN-BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 02400 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MEDOS INT SPINE |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN CAGE/SPACER |
| Generic Name | POLYMERIC SPINAL FUSION CAGE, NON-STERILE |
| Product Code | MQP |
| Date Received | 2020-02-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL CH |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |