MAUDE Adverse Event Report: ZIMMER SPINE TRINICA IMPLANT GENERIC

Model Number TRINICA IMPLANT GENE

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Muscle Spasm(s) (1966); Pain (1994); Tingling (2171)

Event Type  Injury  

Manufacturer Narrative

It is indicated that the device will not be returned for evaluation, and the device part number or lot number were not provided so no record review can be performed.As indicated in the event detail from maude, device prominence may have contributed to this event.This is the final report that will be submitted associated with this incident and device.No additional action is required at this time.

Event Description

It was reported that after implantation of a trinica anterior cervical plate, the patient has experienced postoperative pain, spurring in the spine, breathing problems, nerve spasm, and tingling and knots in the throat.

• Brand Name: TRINICA IMPLANT GENERIC
• Type of Device: TRINICA IMPLANT GENERIC
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer (Section G): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer Contact: scott lapointe ; 7375 bush lake road; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 5024398
• MDR Text Key: 23801413
• Report Number: 2184052-2015-00084
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TRINICA IMPLANT GENE
• Device Catalogue Number: TRINICA IMPLANT GENE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention