MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-06-13 for NORIAN DRILLABLE INJECT 5CC-STERILE 07.704.005S manufactured by Wrights Lane Synthes Usa Products Llc.
[110879860]
Implant date and explant date is not applicable as product was not utilized. A device history record review was requested. 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
[110879861]
It was reported that during an open reduction internal fixation (orif) of the of tibial plateau on (b)(6) 2018. The 5 cc norian drillable inject was finished mixing using the rotary mixer and it would not transfer into the delivery syringe. There was a surgical delay of 2 minutes. The surgery was completed successfully using the 3 cc norian. There was no patient consequence reported. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-52485 |
| MDR Report Key | 7595949 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-13 |
| Date of Report | 2018-05-15 |
| Date of Event | 2018-05-15 |
| Date Mfgr Received | 2018-07-13 |
| Device Manufacturer Date | 2018-01-26 |
| Date Added to Maude | 2018-06-13 |
| 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 | 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 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NORIAN DRILLABLE INJECT 5CC-STERILE |
| Generic Name | MANDIBULAR CONDYLE PROSTHESIS |
| Product Code | MOV |
| Date Received | 2018-06-13 |
| Returned To Mfg | 2018-05-30 |
| Model Number | 07.704.005S |
| Catalog Number | 07.704.005S |
| Lot Number | DSE8240 |
| Device Expiration Date | 2019-09-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-13 |