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 2018-01-30 for DISPENSER, CEMENT manufactured by Oberdorf : Synthes Produktions Gmbh.
[98577231]
Patient information is unknown. Pma / 510k: this report is for unknown needles - unknown lot; unknown part; unknown udi. Device is an instrument and is not implanted/explanted. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[98577232]
It was reported that a surgery was planned: stenoplasty with vertebral body stent system (vbs) and vertecem v + took place on (b)(6) 2017, but cement has "tied-off" faster than usual, the cement needles could not be removed. The trocars and cement needles were cut off as close as possible to the pedicles and a portion remained in the patient. It was noted that moving the "cement seals" in the vertebral body. Decision of the surgeon, perform a long initial stretching and spinal fusion with another manufacturer's product for stabilization of the situs, thoracic 10-11 and lumbar 1-2, since the stent-cement application was no longer considered stable. It was reported the surgeon noted the odor of the monomer remained in the operating room longer than usual. This complaint involves two (2) devices. This complaint is for the unknown needles. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-50699 |
| MDR Report Key | 7227675 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-30 |
| Date of Report | 2018-01-08 |
| Date of Event | 2017-12-30 |
| Date Mfgr Received | 2018-01-08 |
| Date Added to Maude | 2018-01-30 |
| 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 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2018-01-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF : SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-30 |