MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-26 for TRANSITION 152.612 manufactured by Globus Medical, Inc..
[101161088]
An image was provided showing the broken transition 2-level implant, 60mm rod, x-lordotic, 22m, which was removed during surgery. The spool portion of the rod subcomponent appears to have broken adjacent to the cord grip. The cord shows to have remained intact between the cord grip and the crimp housing/pin. The implant was not returned for evaluation and the exact cause of the implant breakage cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[101161089]
It was reported on (b)(6) 2018 that a transition implant broke and needed to be removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004142400-2018-00007 |
| MDR Report Key | 7297610 |
| Date Received | 2018-02-26 |
| Date of Report | 2018-03-01 |
| Date of Event | 2018-01-30 |
| Date Mfgr Received | 2018-01-30 |
| Date Added to Maude | 2018-02-26 |
| 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, 60MM ROD, X-LORDOTIC, 22MM |
| Product Code | NQP |
| Date Received | 2018-02-26 |
| Returned To Mfg | 2018-02-27 |
| Model Number | 152.612 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-02-26 |