MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-12-21 for MIS TI CFX FEN POLY 7X40 186727740 manufactured by Medos International Sàrl Ch.
[131899564]
(b)(4). Device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation 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
[131899565]
The following was reported: depuy 18-78. The head of the screw dislocated during the insertion. The implant was replaced.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1526439-2018-51187 |
MDR Report Key | 8189135 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2018-12-21 |
Date of Report | 2018-12-10 |
Date of Event | 2018-11-15 |
Date Mfgr Received | 2018-12-19 |
Date Added to Maude | 2018-12-21 |
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 | 325 PARAMOUNT DRIVE |
Manufacturer City | RAYNHAM MA 02767 |
Manufacturer Country | US |
Manufacturer Postal | 02767 |
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 | MIS TI CFX FEN POLY 7X40 |
Generic Name | BONE CEMENT, POSTERIOR SCREW AUGMENTATION |
Product Code | PML |
Date Received | 2018-12-21 |
Model Number | 186727740 |
Catalog Number | 186727740 |
Lot Number | 215213 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
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. Required No Informationntervention | 2018-12-21 |