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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. INNER SHAFT, STANDARD INSERTER; ZYSTON STRUT OPEN TITANIUM SPACER SYSTEM
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ZIMMER BIOMET SPINE INC. INNER SHAFT, STANDARD INSERTER; ZYSTON STRUT OPEN TITANIUM SPACER SYSTEM Back to Search Results
Catalog Number 137M0003
Device Problems Detachment of Device or Device Component (2907); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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.Reference report 3012447612-2019-00054.
 
Event Description
It was reported that an inserter jammed and would not release from the implant during surgery.The inserter disassembled after manipulation by the surgeon.An alternative inserter was used to complete the procedure.There were no reported patient impacts associated with this event.This is report two of two for this event.
 
Manufacturer Narrative
Udi number: (b)(4).Additional information: method, results, and conclusions - the returned device was examined.The inner and outer shaft were jammed together upon receipt.After they were separated, the inner shaft was evaluated; there were no malfunctions detected.A review of the manufacturing records did not identify any issues which would have contributed to this event.
 
Event Description
It was reported that an inserter jammed and would not release from the implant during surgery.The inserter disassembled after manipulation by the surgeon.An alternative inserter was used to complete the procedure.There were no reported patient impacts associated with this event.This is report two of two for this event.
 
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Brand Name
INNER SHAFT, STANDARD INSERTER
Type of Device
ZYSTON STRUT OPEN TITANIUM SPACER 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
ashley mcpherson
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key8320035
MDR Text Key135513994
Report Number3012447612-2019-00055
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171495
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number137M0003
Device Lot Number984801
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2018
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 Weight95
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