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 2020-02-13 for UNKNOWN LOCKING/SET SCREWS manufactured by Medos International Sàrl Ch.
[185538658]
This report is for an unknown locking/set screws/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: reporter is company sales consultant. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[185538659]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017, the expedium system was applied in an unknown procedure. On (b)(6) 2020 a revision procedure (mob; multiple operated back) in t12, l1-l4, 5 was performed to treat purulent spondylitis. The procedure was completed less than a 30-minute surgical delay. The procedure and patient outcome were unknown. This compliant will capture the post -op event (revision to treat the purulent spondylitis) while related complaint (b)(4) will capture the intra- op event (the driver shaft? S tip was twisted off during revision). Concomitant devices reported: rods (part # unknown, lot # unknown, quantity unknown). Screws (part # unknown, lot # unknown, quantity unknown). Locking/set screws (part # unknown, lot # unknown, quantity unknown). This report is for an unknown locking/set screws. This is report 6 of 6 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00553 |
| MDR Report Key | 9707958 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-13 |
| Date of Report | 2020-01-27 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-02-13 |
| 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 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN LOCKING/SET SCREWS |
| Generic Name | ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION |
| Product Code | MNH |
| Date Received | 2020-02-13 |
| 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 | 2020-02-13 |