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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 2.3MM PEDICLE PROBE
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ZIMMER BIOMET SPINE INC. 2.3MM PEDICLE PROBE Back to Search Results
Catalog Number 14-500117
Device Problem Fracture (1260)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 06/21/2018
Event Type  Injury  
Manufacturer Narrative
Udi number: ni without a product return, no product evaluation is able to be conducted.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 tip of a probe broke off during impaction while preparing a screw hole during surgery.The tip was unable to be removed and remains within the pelvis.There was a surgical delay greater than 30 minutes associated with this event.There have been no reports of injuries associated with the delay or with the fragment.
 
Manufacturer Narrative
Udi number: na.Additional information: udi number; the device was not returned.However, a photo of an x-ray was provided and used for evaluation.The tip was confirmed to have fractured off.The cause cannot be established based on the provided information.A review of the manufacturing records did not identify any issues which would have contributed to this event.
 
Event Description
It was reported that the tip of a probe broke off during impaction while preparing a screw hole during surgery.The tip was unable to be removed and remains within the pelvis.There was a surgical delay greater than 30 minutes associated with this event.There have been no reports of injuries associated with the delay or with the fragment.
 
Manufacturer Narrative
Additional information: method and conclusion - the returned probe was evaluated.Visual inspection revealed that the tip has fractured off.It is likely that the doctor hammered the probe in an off-axis manner that exceeded the limitations of the probe which subsequently caused the device to fracture.
 
Event Description
It was reported that the tip of a probe broke off during impaction while preparing a screw hole during surgery.The tip was unable to be removed and remains within the pelvis.There was a surgical delay greater than 30 minutes associated with this event.There have been no reports of injuries associated with the delay or with the fragment.
 
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Brand Name
2.3MM PEDICLE PROBE
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
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key8094593
MDR Text Key128039462
Report Number3012447612-2018-00941
Device Sequence Number1
Product Code HXB
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number14-500117
Device Lot Number550484
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/26/2018
Initial Date FDA Received11/21/2018
Supplement Dates Manufacturer Received01/25/2019
03/06/2019
Supplement Dates FDA Received01/30/2019
03/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age61 YR
Patient Weight76
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