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 2020-01-10 for SAGITTAL IN-SITU BENDER, LEFT 299704195 manufactured by Medos International Sàrl Ch.
[177173500]
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is company sales consultant. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[177173501]
Device report from synthes reports an event in (b)(6) as follows: it was reported that during spinal fusion procedure on (b)(6) 2019, the tip of the sagittal in-situ bender broke during bending process. Fragments were generated and were removed easily without additional intervention. There was no surgical delay reported. Another instrument was used to complete the procedure. Procedure was successfully completed. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00341 |
| MDR Report Key | 9575264 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-18 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2016-04-15 |
| Date Added to Maude | 2020-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MEDOS INTERNATIONAL S |
| 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 | SAGITTAL IN-SITU BENDER, LEFT |
| Generic Name | BENDER |
| Product Code | HXW |
| Date Received | 2020-01-10 |
| Returned To Mfg | 2020-01-31 |
| Model Number | 299704195 |
| Catalog Number | 299704195 |
| Lot Number | GB73318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-01-10 |