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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 Problems Fracture (1260); Difficult to Insert (1316)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/01/2020
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 while the surgeon was removing the probe, the tip broke off in the pedicle.The tip remains in the patient.The surgeon did not express concern for the patient's health.Another probe was used to complete the case.There was a 5 minute delay.
 
Manufacturer Narrative
(b)(4).Updated: b4, b5, d4 (lot), g4, h1, h2, h10.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information: b3, d10, h3, h4, h6 (method, results, conclusions).Corrected information in d4: udi number.The complaint is confirmed for one (1) of one (1) returned vitality pedicle probe (pn 07.02072.001) for the failure of fractured tip.Medical records were not provided for review.Potential cause root cause was unable to be determined.This event could possibly be attributed to the hard bone encountered by the pedicle probe, leading to forces greater than what could be handled by the probe.Complaint history there were nine (9) other complaints for similar events related to the same part number in the 12 months leading up to the notification date through to the present.There were three (3) other complaints related to this lot number in all time.An occurrence rate calculation showed that the occurrence falls within that predicted by the risk file.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 and compatibility this device is used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.
 
Event Description
It was reported while the surgeon was removing the probe, the tip broke off in the pedicle.The tip remains in the patient.The surgeon did not express concern for the patient's health.Another probe was used to complete the case.There was a 5 minute delay.
 
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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
MDR Report Key10495076
MDR Text Key205704137
Report Number3012447612-2020-00516
Device Sequence Number1
Product Code HXB
UDI-Device Identifier00889024009943
UDI-Public00889024009943
Combination Product (y/n)N
PMA/PMN Number
SEP 3, 2020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07.02072.001
Device Lot Number102911
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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