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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PEDICLE PROBE - CURVED LUMBAR
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ZIMMER BIOMET SPINE INC. PEDICLE PROBE - CURVED LUMBAR Back to Search Results
Catalog Number 07.02079.001
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/16/2019
Event Type  malfunction  
Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
 
Event Description
It was reported that the tip of the probe broke off in the pedicle.It was retrieved and the case was completed using an alternate device.There were no additional patient impacts or surgical delays reported.
 
Manufacturer Narrative
Additional information in b4, d4 (udi), d10, g4, g7, h2, h3, h4, h6: methods, results, and conclusion codes.Visual inspection revealed a fractured tip.The complaint is confirmed.Three (3) hardness tests of the midsection of the curved part of the shaft resulted in hrc values of 47.0, 48.0, 49.0.The specifications state a minimum of hrc 47, so the complaint product is within spec.A review of the manufacturing records did not identify any issues related to this failure which would have contributed with this event.A definitive root cause cannot be determined.
 
Event Description
It was reported that the tip of the probe broke off in the pedicle.It was retrieved and the case was completed using an alternate device.There were no additional patient impacts or surgical delays reported.
 
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Brand Name
PEDICLE PROBE - CURVED LUMBAR
Type of Device
PROBE
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key9192273
MDR Text Key163346367
Report Number3012447612-2019-00417
Device Sequence Number1
Product Code HXB
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 07/30/2020
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 Number07.02079.001
Device Lot Number63041038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/16/2019
Initial Date FDA Received10/15/2019
Supplement Dates Manufacturer Received07/21/2020
Supplement Dates FDA Received07/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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