MAUDE Adverse Event Report: BIOMET SPAIN, S.L. OMEGA-21 VERTEBRAL FIXATION SYSTEM; SPINE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Event occurred in (b)(6).This device is not manufactured by zimmer biomet in the united states; however, we are filing this report as zimmer biomet manufactures a similar device in the united states under 510k number k061441.The complaint is going to be closed due to the lack of information (lot number has not been provided).Therefore, it has not been possible to perform an investigation.If any additional information becomes available, then the complaint will be reopened and investigated accordingly, and subsequently a supplemental report will be provided where deemed required.

Event Description

It was reported that during the performance of the schedule pms 20 omega-21 vertebral fixation system, the survey performed by dr.(b)(6) (hospital (b)(6)) indicates a breakage of the screws of vertebral fixation system.No additional information is available.

• Brand Name: OMEGA-21 VERTEBRAL FIXATION SYSTEM
• Type of Device: SPINE PROSTHESIS
• Manufacturer (Section D): BIOMET SPAIN, S.L.; calle islas baleares, #50; p.o. box 96; fuente del jarro, valencia 46988 ; SP 46988
• Manufacturer (Section G): BIOMET SPAIN, S.L.; calle islas baleares, #50; p.o. box 96; fuente del jarro, valencia 46988 ; SP 46988
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9738396
• MDR Text Key: 199987183
• Report Number: 0009610576-2020-00001
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1