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 2018-03-20 for CONF PERIMETER MESH KIT 283922000 manufactured by Depuy Spine Inc.
[102894146]
(b)(4). A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. 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
[102894147]
Perimeter mesh presents defect due to cement leakage, which is not contained within the mesh and allows the cement to disperse towards the anterior part of the vertebra without fulfilling the function of recovering the height of the vertebral body. Patient consequence? : yes. Patient consequence description:the vertebra does not recover the height with the cement injection through the perimeter. Action taken for procedure: artrodesan from t11 to l4 to ensure that the xiphosis caused by the injury is corrected. Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes. Product 283922000, lot 5218767. Patient (b)(6), woman, (b)(6). Spine procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2018-50254 |
| MDR Report Key | 7352598 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-20 |
| Date of Report | 2018-02-24 |
| Date of Event | 2018-02-19 |
| Date Mfgr Received | 2018-02-24 |
| Date Added to Maude | 2018-03-20 |
| 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 | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| Manufacturer G1 | MEDOS INT SPINE |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONF PERIMETER MESH KIT |
| Generic Name | UNKNOWN |
| Product Code | EZX |
| Date Received | 2018-03-20 |
| Catalog Number | 283922000 |
| Lot Number | 5218767 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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. Other | 2018-03-20 |