MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,study report with the FDA on 2019-12-05 for AEGIS ANTERIOR LUMBAR PLATE SYSTEM UNK PLATES manufactured by Depuy Spine Inc.
[185270040]
Product complaint # (b)(4). This report is for an unknown plates/unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. J&j reporter (b)(4). 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. Investigation summary product was not returned. Based on the information available, it has been determined that no corrective and preventive action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185270041]
This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients implanted with depuy synthes aegis? Anterior lumbar plate for anterior lumbar interbody fusion procedures failed anterior lumbar interbody fusion has been identified as the reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: 8 patients had a new surgical reoperation procedure within 24 months following the index anterior lumbar interbody fusion for fusion or device removal within the lumbar spine. 1 patient had subsequent surgery for a new surgical procedure within 90 days following the index anterior lumbar interbody fusion for non-fusion surgeries (excluding device removal) in any region of the lumbar or thoracic spine. This is for (b)(6) study. This report is for one (1) unknown plate/aegis anterior lumbar plate system. This report is 4 of 9 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-52600 |
| MDR Report Key | 9419383 |
| Report Source | COMPANY REPRESENTATIVE,STUDY |
| Date Received | 2019-12-05 |
| Date of Report | 2019-11-12 |
| Date Mfgr Received | 2019-11-12 |
| Date Added to Maude | 2019-12-05 |
| 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 | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AEGIS ANTERIOR LUMBAR PLATE SYSTEM |
| Generic Name | AWL, VARIABLE |
| Product Code | HWJ |
| Date Received | 2019-12-05 |
| Catalog Number | UNK PLATES |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE INC |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-05 |