MAUDE Adverse Event Report: ZIMMER SPINE TRINICA SELECT CERVICAL PLATE, 63MM 3LVL

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Unspecified Infection (1930)

Event Date 07/15/2016

Event Type  Injury  

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.The user facility is foreign; therefore a facility medwatch report will not be available.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

The sales associate reported a patient was implanted with 3x icotec cage (the cage is made from carbon/peek material and is fully coated with a porous titanium layer), trinica plate and z bone putty.The patient had an infection and several swabs were taken, no germs were present.Revision was performed on (b)(6) 2016.All implants and the z bone putty were removed and sent to histology.The wound has been opened and rinsed several times.When removing the cranial located cage, pus came out.Since no germs were detected, the doctor assumes that the patient is reacting to the z-bone putty.New 3x tm s 100 and trinica plate were used.The doctor suspects allergic reaction to the z-bone putty.The screw item numbers are unknown.

• Brand Name: TRINICA SELECT CERVICAL PLATE, 63MM 3LVL
• Type of Device: CERVICAL PLATE
• 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: michelle cole ; 7375 bush lake road; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 5871570
• MDR Text Key: 51949289
• Report Number: 0002184052-2016-00159
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PK132012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 07.00342.005
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• 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: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR