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 2020-02-25 for CONFIDENCE SPINAL CMT SYS, 11C 283910000 manufactured by Medos International Sàrl Ch.
[182235137]
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Initial reporter is synthes sales representative. The cement mixer, reservoir, and amber epoxy vial of the 11cc confidence spinal cement kit (product code: 2839-10-000, lot number: 257450) were returned to the complaint handling unit (chu) on january 17th, 2020. There is a small volume (2cc) of cement on the rotor of the cement mixer. The remaining cement was found at the bottom of the cement mixer with the reservoir attached. The cement failed to properly enter the base of the reservoir, instead solidifying in the mixer. A review of the cement? S manufacturing records found no issues. There is a possibility the cement may have solidified prematurely due to the manner with which it was stored and other environmental factors that might have an impact on the cement? S setting time. A review of the device history record (dhr) was performed on the 11cc confidence spinal cement kit (product code: 2839-10-000, lot number: 257450). This lot was produced as a single batch consisting of 48 units which were released to stock on october 24th, 2019. No discrepancies were observed during the manufacturing process. As a result, a review of the dhr identified no issues during the manufacturing and release of this kit that could contribute to the problem reported by the customer. This kit was released accomplishing all quality requirements. The root cause of the cement setting prematurely cannot be determined from the sample and the information provided. A potential root cause may be environment factors related to the storage of the cement. The confidence spinal cement system kit? S instructions for use states that the cement should be stored unopened in its original packaging, in a dry, clean place away from light, at a maximum temperature between 41? F (5? C) and 77? F (25? C). Working time at operating room and material temperature of 20 degrees celsius is 9 minutes. The handling characteristics and setting time can vary if the product has not been fully equilibrated at 68? F (20? C) before use. The unopened product should be stored at 68? F (20? C) for a minimum of 24 hours before use. No other potential defects were observed. No corrective and preventive action (capa) is necessary at this time as no issues could be identified in the manufacturing or release of these products. Therefore, this complaint will be closed with no further action required. A review of the device history record (dhr) was performed on the 11cc confidence spinal cement kit (product code: 2839-10-000, lot number: 257450). This lot was produced as a single batch consisting of 48 units which were released to stock on october 24th, 2019. No discrepancies were observed during the manufacturing process. As a result, a review of the dhr identified no issues during the manufacturing and release of this kit that could contribute to the problem reported by the customer. This kit was released accomplishing all quality requirements. A follow-up dhr review was performed on the high viscosity spinal cement that is part of this kit (product code: 1839-01-001, lot number: 9207064). Expiration date is december 31st, 2021. No discrepancies were observed during the manufacturing process. Final micro and sterility tests passed. A complaint database search finds no additional reports against the provided product and lot combination related to this complaint. Based on the inability to find any other related incidents against the provided product and lot code, it is reasonable to conclude that there are no anomalies regarding manufacturing or inspection contained in the device history records that would contribute to the reported event. This information was provided by supplier cmw. 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
[182235138]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the confidence cement failed to exit the plastic vial. No further information is available. This report is for confidence spinal cmt sys, 11c. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00620 |
| MDR Report Key | 9751462 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2019-10-24 |
| Date Added to Maude | 2020-02-25 |
| 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 | CONFIDENCE SPINAL CMT SYS, 11C |
| Generic Name | CEMENT, BONE, VERTEBROPLASTY |
| Product Code | NDN |
| Date Received | 2020-02-25 |
| Returned To Mfg | 2020-01-17 |
| Model Number | 283910000 |
| Catalog Number | 283910000 |
| Lot Number | 257450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-25 |