MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-05-18 for MESH 17X22MM OVAL 50MM HEIGHT 174148000 manufactured by Depuy Synthes Spine.
[45440612]
(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. Sample not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[45440613]
This complaint is the update of (b)(4). The index surgery was performed on (b)(6) 2010 to remove a malignant struma ovarii and metastatic spinal tumor at the l3, and the reported surgical titanium mesh and an expedium-di system were implanted to the l1-l5. On (b)(6) 2014, it was confirmed that the mesh had started to get kinked. Although the surgeon decided to observe the condition at this point, on (b)(6) 2014, a breaking sound was heard from the body. The patient was followed-up on (b)(6) 2014, and it was confirmed that the left rod was broken and the titanium mesh was kinked in anterior direction. The revision was performed on (b)(6) 2014. The expedium was removed, and a solera (medtronic) was implanted to th12-s1. The x-ray photo taken after the revision seemed to indicate that the kink of the mesh was fixed. However, another breaking sound was heard from the body on (b)(6) 2016, and on (b)(6) 2016 it was confirmed that the left rod was broken and the titanium mesh was kinked again. Another revision is scheduled on (b)(6) 2016, and the mesh with will be replaced with a syncage-ex system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2016-10347 |
| MDR Report Key | 5664121 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-05-18 |
| Date of Report | 2016-04-20 |
| Date of Event | 2016-04-12 |
| Date Mfgr Received | 2016-04-20 |
| Device Manufacturer Date | 2009-10-14 |
| Date Added to Maude | 2016-05-18 |
| 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 JACENE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5089776485 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MESH 17X22MM OVAL 50MM HEIGHT |
| Generic Name | MESH, SURGICAL, METAL |
| Product Code | EZX |
| Date Received | 2016-05-18 |
| Catalog Number | 174148000 |
| Lot Number | 5073727 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-05-18 |