MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-05-31 for IMPLANT, FIXATION DEVICE, SPINAL manufactured by Synthes (usa).
[76311923]
(b)(6). Patient weight not available for reporting. 510k: this report is for an unknown spinal implant. Part and lot numbers are unknown; udi number is unknown. It is not verified that device is a synthes manufactured device. Date of explant reported as sometime in (b)(6) 2017. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(6). 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
[76311924]
It was reported that a patient has expressed that her three-level cervical spine fusion at c5, c6, c7, that took place on (b)(6) 2016 was unsuccessful, the implants were infected with (b)(6). The patient underwent a revision procedure this past month on an unknown date. The amount of devices that were removed is unknown and if the patient was revised to other hardware. It is also unknown who manufactured the implants. It was only reported that it could be depuy synthes or depuy spine. Surgical delay or patient harm during the initial and revision procedures are also unknown. This report is for one (1) unknown spine implant this is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-11751 |
| MDR Report Key | 6602383 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-05-31 |
| Date of Report | 2017-05-07 |
| Date Mfgr Received | 2017-05-07 |
| Date Added to Maude | 2017-05-31 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | IMPLANT, FIXATION DEVICE, SPINAL |
| Product Code | JDN |
| Date Received | 2017-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-31 |