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 2020-03-27 for MILAGRO INSCR SMALL SIZE 6X30 231809 manufactured by Depuy Mitek Llc Us.
[185602068]
(b)(4). 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. Udi: (b)(4). The lot number is unknown.
Patient Sequence No: 1, Text Type: N, H10
[185602069]
It was reported by affiliate via complaint submission tool that a month after procedure the milagro inscr small size 6x30 screw moved upwards into the joint space, as a consequence the patient had strange feeling in the popliteus, a surgery was performed and the surgeon was not able to remove the screw. The device is not available to be returned for evaluation. Additional information provided by the affiliate reported the surgeon reported the patient feels something disturbing to him near his popliteus. It was reported an x-ray is scheduled to occur some time soon but the exact time is unknown. The affiliate reported it was unknown if the screw has caused any addition harm or what the patient's prognosis maybe. It was also reported the lot number is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2020-01005 |
| MDR Report Key | 9890985 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-27 |
| 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 MITEK |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 02400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILAGRO INSCR SMALL SIZE 6X30 |
| Generic Name | ORTHOPAEDIC BONE SCREW, BIOABSORBABLE |
| Product Code | MAI |
| Date Received | 2020-03-27 |
| Model Number | 231809 |
| Catalog Number | 231809 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |