MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 TI 6.5X40MM CANNULATED TRANSLATION SCREW; POLARIS SPINAL SYSTEM -TRANSLATION SCREW

Catalog Number 14-571440

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problem Failure of Implant (1924)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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.Reference reports 3012447612-2021-00278 through 3012447612-2021-00280.

Event Description

It was reported that a revision surgery was performed after a patient presented with a squeaking noise coming from the implanted construct during movement.During the revision, it was found that the threaded shaft of the pedicle screw at left l5 had fractured.Additionally, the rod on the right side of the construct was able to move medially/laterally because one of the pedicle screw heads did not maintain its position.The fractured screw, both rods, and four plugs were removed and replaced.This is report one of three for this event.

Manufacturer Narrative

Corrected information in d2: common device name; d4: catalog number, lot number, and udi number; d9; g4; and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed the screw shank has fractured.Potential cause root cause was unable to be determined.This event could possibly be attributed to unknown patient factors or traumatic events.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.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 revision surgery was performed after a patient presented with a squeaking noise coming from the implanted construct during movement.During the revision, it was found that the threaded shaft of the pedicle screw at left l5 had fractured.Additionally, the rod on the right side of the construct was able to move medially/laterally because one of the pedicle screw heads did not maintain its position.The fractured screw, both rods, and four plugs were removed and replaced.This is report one of three for this event.

• Brand Name: 5.5 TI 6.5X40MM CANNULATED TRANSLATION SCREW
• Type of Device: POLARIS SPINAL SYSTEM -TRANSLATION SCREW
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 12233388
• MDR Text Key: 263839732
• Report Number: 3012447612-2021-00278
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K140123
• 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: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-571440
• Device Lot Number: 2350411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR