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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PEDICLE PROBE - CURVED LUMBAR LENKE
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ZIMMER BIOMET SPINE INC. PEDICLE PROBE - CURVED LUMBAR LENKE Back to Search Results
Catalog Number 07.02072.001
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2022
Event Type  malfunction  
Event Description
It was reported that a vitality lenke probe fractured during a case.All pieces were successfully recovered from the patient anatomy.Another probe was used to complete the case without patient impacts.
 
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.
 
Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned, but a photo was provided.The photo shows that the tip of the probe broke off in the area of the flat-to-round transition.Potential cause: root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.It could also be attributed to the hardness of the patient's bone.Dhr review: dhr review unable to be performed as lot information is not known.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.
 
Event Description
It was reported that a vitality lenke probe fractured during a case.All pieces were successfully recovered from the patient anatomy.Another probe was used to complete the case without patient impacts.
 
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Brand Name
PEDICLE PROBE - CURVED LUMBAR LENKE
Type of Device
PROBE
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
kim martinez
10225 westmoor dr.
na
westminster, CO 80021
3035144809
MDR Report Key15831077
MDR Text Key305786830
Report Number3012447612-2022-00269
Device Sequence Number1
Product Code HXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07.02072.001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/26/2022
Initial Date FDA Received11/19/2022
Supplement Dates Manufacturer Received04/17/2023
Supplement Dates FDA Received04/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexFemale
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