MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. TRINICA SELF DRILLING SCREW VARIABLE, UNKNOWN SIZE; SEE H10

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

Procode: trinica(r) anterior cervical plate system, trinica(r) select anterior cervical plate system.Reference reports 3012447612-2021-00020 thru 3012447612-2021-00027.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

It was reported that a screw fractured and backed out post-op, which caused the construct to be unstable and fusion was not achieved.Additionally, the cage was found to be cracked.A 2-level plate, 6 screws, and cage were removed during a revision surgery.This is report six of eight for this event.

Event Description

It was reported that a screw fractured and backed out post-op, which caused the construct to be unstable and fusion was not achieved.Additionally, the cage was found to be cracked.A 2-level plate, 6 screws, and cage were removed during a revision surgery.This is report six of eight for this event.

Manufacturer Narrative

Added information to d3: email address, d8, h6: component codes, health effect-impact code, type of investigation, investigation findings, investigation conclusions this follow-up report is being submitted to relay additional information and initially corrected information.Summary: the complaint is confirmed for one (1) of six (6) returned 10x4.2mm sd var scr (pn: 07.00812.0xx) for the failure of screw fractured and migrated post-operation.The complaint is confirmed for five (5) of six (6) returned 10x4.2mm sd var scr (pn: 07.00812.0xx) for the failure of construct did not provide fusion.T.Medical records were provided in form of x-rays.The provided x-rays confirms that an implant was migrated.Potential cause despite the products were returned for evaluation, root cause can't be established.Patient conditions and events prior to the surgery are not known.Insufficient information was provided.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: TRINICA SELF DRILLING SCREW VARIABLE, UNKNOWN SIZE
• Type of Device: SEE H10
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11302448
• MDR Text Key: 231007462
• Report Number: 3012447612-2021-00025
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K132012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 07.00812.0XX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention