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 2020-03-13 for EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5 199721000 manufactured by Medos International Sàrl Ch.
[184350358]
Initial reporter is synthes sales representative. 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
[184350359]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, several expedium verse dual innies broke intraoperatively in a complex "skoliosis" case. The surgeon claims that "inpropper" handling can be excluded. Outer ring of dual innie broke while final "tighetening". Broken dual innies also destroyed the thread of the implanted screws. The polyaxial mechanisms of another screw head blocked and needed to be replaced. There was a surgical delay of thirty (30) minutes. Concomitant devices reported: expedium verse spine system verse correction key 5. 5 (part#: 199721000, lot#: unknown, quantity#: 8), 5. 5 exp verse fen scr 5. 0x45 (part#: unknown, lot#: unknown, quantity#: 9), unknown mono/polyaxial screws (part#: unknown, lot#: unknown, quantity#: 1). This report is for one (1) expedium verse spine system verse correction key 5. 5 this is report 6 of 8 for (b)(4). This (b)(4) capture the 9 out of 19 devices reported and (b)(4) capture the 10 out of 19 devices reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00710 |
| MDR Report Key | 9829900 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-13 |
| 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 |
| 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 | EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5 |
| Generic Name | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
| Product Code | KWQ |
| Date Received | 2020-03-13 |
| Model Number | 199721000 |
| Catalog Number | 199721000 |
| 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 | 2020-03-13 |