MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 TI 6.5X50MM TRANSLATION SCREW POLARIS SPINAL SYSTEM -TRANSLATION SCREW

Catalog Number 14-578450

Device Problems Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Death (1802); Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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. Reference reports 3012447612-2020-00360 to 3012447612-2020-00375.

Event Description

It was reported that 16 polaris screws were found to have disassembled postoperatively after the patient reported pain and discomfort. A revision was preformed where all screws were removed and replaced with alternate polaris screws. Additionally, during the revision, all 16 plugs were found to have migrated or loosened from the screws. There were no additional patient impacts reported. This is report eleven of sixteen.

Manufacturer Narrative

Additional information: b2, b5, h1, h6 (patient code).

Event Description

It was reported that (b)(4) polaris screws were found to have disassembled postoperatively after the patient reported pain and discomfort. A revision was preformed where all screws were removed and replaced with alternate polaris screws. Additionally, during the revision, all (b)(4) plugs were found to have migrated or loosened from the screws. There were no additional patient impacts reported. Additional information was provided which stated the patient has passed away due to covid-19 and it is not believed that the polaris construct contributed to the patient¿s passing. This is report eleven of sixteen.

Event Description

It was reported that 16 polaris screws were found to have disassembled postoperatively after the patient reported pain and discomfort. A revision was preformed where all screws were removed and replaced with alternate polaris screws. Additionally, during the revision, all 16 plugs were found to have migrated or loosened from the screws. There were no additional patient impacts reported. This is report eleven of sixteen.

Manufacturer Narrative

Additional information in b7, d1 (brand name), d4 (catalog number and lot number), d10, e1 (middle name), h3 and h6 (method). Current information is insufficient to permit a valid conclusion about the cause of this event. A follow-up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

Correction to h1. Additional information: b5, h6 (patient code).

Event Description

A subsequent additional update was reported stating that the patient has not passed away but was admitted to the er for a l5 pedicle fracture and vertebral body fracture and was reported to be bedridden. No procedures have been scheduled, and the most recently received update was that the patient was discharged from the hospital.

Event Description

It was reported that 16 translating screws were found to have disassembled postoperatively after the patient reported pain and discomfort. A revision was preformed where all screws were removed and replaced with standard polyaxial screws. There were no additional patient impacts reported with this event. This is report eleven of sixteen for this event.

Manufacturer Narrative

Corrections in h6: impact and clinical. Additional information in d4: udi number; h4; h6: component, investigation type, results, and conclusions; and h7. This follow-up report is being submitted to relay additional information. The complaint is confirmed for 16 returned translation screws for the reported failure of trolley failure due to reaction with spf, allowing the screws to disassemble in-vivo. The dhrs were reviewed. There are no indications of manufacturing issues that would have contributed to this event and the screws were likely conforming when they left zimmer biomet¿s control. The associated ifu was updated and the user was notified. An internal capa is investigating the cause.

• Brand Name: 5.5 TI 6.5X50MM 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: 10330501
• Report Number: 3012447612-2020-00370
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 14-578450
• Device Lot Number: 2338191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0570-2021
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Other; Required Intervention