MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2020-02-06 for NUVASIVE COROENT SYSTEM manufactured by Nuvasive Inc..
[177984649]
No product has been returned for investigation as no product malfunction was alleged. Even though no product malfunction was identified nor product used, procedure performed was an xlif. No further information is available. Literature review: potential adverse events and complications: "as with any major surgical procedures, there are risks involved in spinal/ orthopedic surgery. Potential risks identified with the use of this system, which may require additional surgery, include: neurological, vascular or visceral injury. "
Patient Sequence No: 1, Text Type: N, H10
[177984650]
During literature review it was identified that between the dates of (b)(6) 2014 and (b)(6) 2015, a patient underwent a revision procedure for a sagittal imbalance after an l3-s1 level fusion. The patient presented a moderately tense abdomen on postoperative day one. On postoperative day two, a ct scan of the abdomen revealed a bowel perforation. Patient was transferred to general surgery department where he received a partial colectomy, temporary colostomy. During the procedure, a needle perforation was found in the descending colon at l4-l5 level. No information available on resolution or on devices and instrumentation used during procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2020-00015 |
| MDR Report Key | 9676934 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-09 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-02-06 |
| 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 | MR. YOBANA SANCHEZ |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8589093383 |
| Manufacturer G1 | NUVASIVE, INC. |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUVASIVE COROENT SYSTEM |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| Date Received | 2020-02-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE INC. |
| Manufacturer Address | 7475 LUSK BOULEVARD SAN DIEGO 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-06 |