MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-08-07 for XEMFLIFI DBM PLUS, 3CC 8103.0203S manufactured by Globus Medical, Inc..
[22538638]
A comprehensive investigation was immediately initiated on receipt of the complaint. The product was not returned for evaluation. A thorough investigation was completed, and no deviations to processing were identified. There have been no previous reported issues of this type. Xemplifi plus is a sterile packaged product. Sterility can be assured as long as the product package is not compromised. In this case, there was no reported issues with the sterility of the product. Postoperative infection can be caused from a wide variety of sources. In this event, it is not possible to determine the exact cause of the infection. This report is associated with mdr (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[22538639]
It was reported to globus that a patient had a fusion surgery c5-6 on (b)(6) 2016 at (b)(6) hospital (b)(6). The patient later developed an abscess/infection, and had to have the spinal hardware, coalition spacer, and xemplifi putty removed. The removal surgery took place (b)(6) 2015. The removal surgery was performed at (b)(6) hospital (b)(6). The removal surgery was performed by different surgeon than the initial surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004142400-2015-00032 |
| MDR Report Key | 4990515 |
| Report Source | OTHER |
| Date Received | 2015-08-07 |
| Date of Report | 2015-07-14 |
| Date of Event | 2015-03-13 |
| Date Mfgr Received | 2015-07-14 |
| Date Added to Maude | 2015-08-11 |
| 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 | DANIEL PAUL, VP, QA & IT |
| Manufacturer Street | 2560 GENERAL ARMISTEAD AVE. |
| Manufacturer City | AUDUBON PA 19403 |
| Manufacturer Country | US |
| Manufacturer Postal | 19403 |
| Manufacturer Phone | 6109301800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XEMFLIFI DBM PLUS, 3CC |
| Generic Name | XEMPLIFI DBM |
| Product Code | MBP |
| Date Received | 2015-08-07 |
| Model Number | 8103.0203S |
| Lot Number | 1362376553 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLOBUS MEDICAL, INC. |
| Manufacturer Address | 2560 GENERAL ARMISTEAD AVE. AUDUBON PA 19403 US 19403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-07 |