MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-22 for TRANSITION manufactured by Globus Medical, Inc..
[101125464]
The implants were not returned for evaluation as they remain in the patient. No determination can be made as to the cause of the reported issue.
Patient Sequence No: 1, Text Type: N, H10
[101125465]
Images were provided showing a transition component on the right side which appears to have broken. No revision surgery has taken place.
Patient Sequence No: 1, Text Type: D, B5
[131704252]
The implants were not returned for evaluation as they remain in the patient. No determination can be made as to the cause of the reported issue.
Patient Sequence No: 1, Text Type: N, H10
[131704253]
Images were provided showing a transition component on the right side which appears to have broken. No revision surgery has taken place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004142400-2018-00008 |
| MDR Report Key | 7290669 |
| Date Received | 2018-02-22 |
| Date of Report | 2018-03-13 |
| Date of Event | 2018-01-23 |
| Date Mfgr Received | 2018-01-23 |
| Date Added to Maude | 2018-02-22 |
| 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. DANIEL PAUL |
| Manufacturer Street | 2560 GENERAL ARMISTEAD AVENUE |
| Manufacturer City | AUDUBON PA 19403 |
| Manufacturer Country | US |
| Manufacturer Postal | 19403 |
| Manufacturer Phone | 6109301800 |
| Manufacturer G1 | GLOBUS MEDICAL INC. |
| Manufacturer Street | 2560 GENERAL ARMISTEAD AVENUE |
| Manufacturer City | AUDUBON PA 19403 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19403 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRANSITION |
| Generic Name | TRANSITION 2 LEVEL IMPLANT, LORDOSED |
| Product Code | NQP |
| Date Received | 2018-02-22 |
| 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 AVENUE AUDUBON PA 19403 US 19403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-22 |