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 2017-11-09 for PRODISC-C VIVO UNCEM CONVEX SIZ M 15*12 04.670.927S manufactured by Synthes Hagendorf.
[91495547]
Patient information is unknown. (b)(4). (b)(6). Device is not distributed in the united states, but is similar to device marketed in the usa. A device history record review was performed for the subject device lot number 9342031. Manufacturing location: (b)(4). Date of manufacture: 29. Jan. 2015. Expiry date: 01. Jan. 2020. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. (b)(4). 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
[91495548]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a prodisc c vivo size m, 15 mm x 12 mm, h7mm was requested by surgeon and after being removed from it's outer box a small hole was observed in the sterile packaging. Sales rep observed the removal of the unusable item and there is no way that the damage was caused by the person that removed it. The surgeon then requested the next size down as there was only one of this size in the loan kit. This implant was intact on the second implant and was used for the case. Concomitant parts reported: 1x prodisc? -c vivo, uncemented (part 04. 670. 927s lot 9342031). This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003875359-2017-10554 |
| MDR Report Key | 7013734 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-09 |
| Date of Report | 2017-10-17 |
| Date of Event | 2017-10-16 |
| Date Mfgr Received | 2017-12-05 |
| Device Manufacturer Date | 2015-01-29 |
| Date Added to Maude | 2017-11-09 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES HAGENDORF |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAGENDORF CH4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRODISC-C VIVO UNCEM CONVEX SIZ M 15*12 |
| Generic Name | IMPLANT, FIXATION DEVICE, SPIN |
| Product Code | JDN |
| Date Received | 2017-11-09 |
| Returned To Mfg | 2017-10-24 |
| Catalog Number | 04.670.927S |
| Lot Number | 9342031 |
| Device Expiration Date | 2020-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES HAGENDORF |
| Manufacturer Address | IM BIFANG 6 HAGENDORF CH4614 SZ CH4614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-09 |