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 2019-11-15 for CAPSTONE CONTROL PTC SPINAL SYSTEM 5011222 manufactured by Mdt Puerto Rico Operations Co, Med Rel.
Report Number | 2647346-2019-00021 |
MDR Report Key | 9325787 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-11-15 |
Date of Report | 2019-11-15 |
Date of Event | 2019-10-18 |
Date Mfgr Received | 2019-10-18 |
Date Added to Maude | 2019-11-15 |
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 | STACIE ZIEMBA |
Manufacturer Street | 1800 PYRAMID PLACE |
Manufacturer City | MEMPHIS TN 38132 |
Manufacturer Country | US |
Manufacturer Postal | 38132 |
Manufacturer Phone | 9013963133 |
Manufacturer G1 | MDT PUERTO RICO OPERATIONS CO, MED REL |
Manufacturer Street | ROAD 909, KM. 0.4., BARRIO MAR |
Manufacturer City | HUMACAO PR 00792 |
Manufacturer Country | US |
Manufacturer Postal Code | 00792 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CAPSTONE CONTROL PTC SPINAL SYSTEM |
Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR |
Product Code | MAX |
Date Received | 2019-11-15 |
Model Number | NA |
Catalog Number | 5011222 |
Lot Number | H5530440 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MDT PUERTO RICO OPERATIONS CO, MED REL |
Manufacturer Address | ROAD 909, KM. 0.4., BARRIO MAR HUMACAO PR 00792 US 00792 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-11-15 |