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 2018-07-19 for UNKNOWN PLATES manufactured by Medos International Sàrl Ch.
[114487011]
(b)(4). A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. 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
[114487012]
This report is being filed after the subsequent review of the following literature article: a comparison of a new zero-profile, stand-alone fidji cervical cage and anterior cervical plate for single and multilevel acdf: a minimum 2-year follow-up study zhonghai li1,2,3? Yantao zhao1,2? Jiaguang tang1,2? Dongfeng ren1,2? Jidong guo1,2? Huadong wang1,2? Li li1,2? Shuxun hou1,2 eur spine j (2017) 26:1129? 1139. Received: 8 december 2015 / revised: 16 july 2016 / accepted: 6 august 2016 / published online: 23 august 2016. N=1: implant dislodgement. N=2: post op breakage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2018-50700 |
| MDR Report Key | 7704033 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-19 |
| Date of Report | 2018-06-21 |
| Date Mfgr Received | 2018-06-21 |
| Date Added to Maude | 2018-07-19 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| 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 PLATES |
| Generic Name | UNKNOWN |
| Product Code | KTW |
| Date Received | 2018-07-19 |
| 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 | 1. Other | 2018-07-19 |