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 2020-03-05 for UNKNOWN CAGE/SPACER manufactured by Medos International Sàrl Ch.
[182174194]
This report is for an unknown cage/spacer/unknown lot. Part and lot numbers are unknown; udi number is unknown. Without a lot number the device history records review could not be completed. Product was not returned. 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
[182174195]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, that patient underwent revision surgery due to infection and sepsis leading to cage becoming dislodged. Surgeon removed posterior instrumentation, inserted alif cages and put new metalwork in posteriorly in third stage operation. All screws were removed and biopsies taken of the pedicles. No further information provided. This report is for one (1) unknown cage/spacer. This is report 4 of 6 for (b)(4). This (b)(4) will capture the post-op event (revision was due previous infection and sepsis leading to cage becoming dislodged), while (b)(4) will capture the intra-op event (difficulty removing the s1 screw).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00652 |
| MDR Report Key | 9792721 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-05 |
| Date of Report | 2020-02-10 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-03-05 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN CAGE/SPACER |
| Generic Name | INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR |
| Product Code | OVD |
| Date Received | 2020-03-05 |
| 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. Required No Informationntervention | 2020-03-05 |