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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5MM X 40MM UNIPLANER SCREW POLARIS SPINAL SYSTEM

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ZIMMER BIOMET SPINE INC. 5.5MM X 40MM UNIPLANER SCREW POLARIS SPINAL SYSTEM Back to Search Results
Catalog Number 14-512340
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 11/16/2020
Event Type  Injury  
Manufacturer Narrative
Device evaluation: the part was discarded by the hospital but the pictures provided show the screw being fractures in the middle of the shaft. The complaint is confirmed. Complaint history: there were zero (0) other complaints for similar events (post-op screw fracture) related to the same part number in the 12 months leading up to the notification date through to the present. Zero (0) additional search results for the lot and item search. 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. Potential cause: this event could possibly be attributed unintended motion of patient post operation, which might have caused the screw to fracture. With the given information, the definitive cause cannot be determined.
 
Event Description
It was reported that a revision was performed to address a screw at bottom of scoliosis construct that broke mid shaft (in pedicle). The rods were cut bilaterally and the bottom screws were removed bilaterally. No new implants were used.
 
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Brand Name5.5MM X 40MM UNIPLANER SCREW
Type of DevicePOLARIS SPINAL SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
na
westminster CO 80021
Manufacturer Contact
jessica buzbee
10225 westmoor dr.
na
westminster, CO 80021
3038034523
MDR Report Key11016347
MDR Text Key221737436
Report Number3012447612-2020-00675
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K100220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number14-512340
Device Lot Number2368691
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/16/2020 Patient Sequence Number: 1
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