MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for INTERARTICULAR DISC PROSTHESIS (INTERPOSITIONAL IMPLANT) manufactured by Wrights Lane Synthes Usa Products Llc.
[141309881]
Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4): the reported event required medical/surgical intervention to preclude permanent damage to a body structure. Patient underwent a removal surgery, the prodisc c was at c3-c4, there were 2 ldr roi-c c4-c6. C5-c6 roi-c did not fuse. 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. 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
[141309882]
It was reported that on an unknown date, the patient underwent a removal surgery, the prodisc c was at c3-c4, there were 2 ldr roi-c c4-c6. C5-c6 roi-c did not fuse. The device was successfully removed. It was unknown if there was a surgical delay. Procedure outcome and patient status are unknown. This complaint involves one (1) device. This report is for one (1) unk - artificial disc replacement: prodisc c. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-57377 |
| MDR Report Key | 8493598 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-03-14 |
| Date Mfgr Received | 2019-05-10 |
| Date Added to Maude | 2019-04-08 |
| 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 | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | INTERARTICULAR DISC PROSTHESIS (INTERPOSITIONAL IMPLANT) |
| Product Code | MPJ |
| Date Received | 2019-04-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-04-08 |