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 2020-01-08 for OPAL SPACER 10MM X 24MM 11MM HEIGHT-REVOLVE 08.803.051 manufactured by Wrights Lane Synthes Usa Products Llc.
[182765522]
Product complaint # (b)(4). 510k: this report is for an unknown unk - cage/spacers: opal /unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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
[182765523]
It was reported that on an unknown date, the patient underwent posterior spinal fusion an opal allograft set-eval on the left side of a patient at the l5/s1 disc space migrated posteriorly. A clinical outcome experienced by the patient was dural tear. Currently, there is no product code for the opal spacer that was removed. It was kept at the facility to run through decontamination. The implant was also burred down using a drill to remove it so lot numbers and product codes are missing. Patient outcome and status were unknown. The cage was successfully explanted, no other devices were involved, no other cage was implanted, and the explanted cage is available for return. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00097 |
| MDR Report Key | 9566740 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-12 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2015-06-10 |
| Date Added to Maude | 2020-01-08 |
| 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 |
| 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 | ELMIRA |
| Manufacturer Street | 35 AIRPORT ROAD |
| Manufacturer City | HORSEHEADS NY 14845 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14845 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPAL SPACER 10MM X 24MM 11MM HEIGHT-REVOLVE |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| Date Received | 2020-01-08 |
| Returned To Mfg | 2020-01-22 |
| Catalog Number | 08.803.051 |
| Lot Number | 9824987 |
| 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 | 2020-01-08 |