MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED TRANSLATION SCREW, UNKNOWN SIZE; SEE H10

Catalog Number 14-571XXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/29/2020

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.

Event Description

It was reported that the blade may have broken off a portion of the sacrum post-operatively.No information regarding treatment has been provided.

Event Description

It was reported that the blade may have broken off a portion of the sacrum post-operatively.No information regarding treatment has been provided.

Manufacturer Narrative

Corrected information in h10: d2 common device name: polaris spinal system - ballista ii percutaneous screw.Placement system or polaris spinal system -translation screw.G5 510k number: k123549 or k140123.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 the blade may have broken off a portion of the sacrum post-operatively.No information regarding treatment has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Summary: the complaint is confirmed for one (1) of one (1) unreturned cypher mis 5.5 ti 5.0x145mm (pn: 14-571xxx) for the failure of patient harm.The product was not returned for evaluation, however, x-rays were provided.The provided x-rays do not reveal any issues with the implants.However, it can be observed that a portion of the sacrum bone is fractured.Potential cause even though the product was not returned for investigation, the provided data in the complaint description suggests that the cause is likely not traced to the device.Per the complaint description, the patient has gone through multiple procedures which could have weaken the patient bone, leading to this event.Additionally, it should be noted that the patient is short and overweight which could have contributed to this event.Dhr review and related actions lot number was not provided, therefore, dhr review can't be performed.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: CANNULATED TRANSLATION SCREW, UNKNOWN SIZE
• Type of Device: SEE H10
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10938222
• MDR Text Key: 219308774
• Report Number: 3012447612-2020-00677
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 14-571XXX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other