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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 4.5 MM DIAMETER 115 MM LENGTH PLATE, FIXATION

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ZIMMER MANUFACTURING B.V. CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 4.5 MM DIAMETER 115 MM LENGTH PLATE, FIXATION Back to Search Results
Catalog Number 00234712315
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Date 03/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source - foreign - (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00170. 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. Product not returned.
 
Event Description
It was reported that the length of the screws are not consistent with the labeling. There was no patient involvement.
 
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Brand NameCORTICAL BONE SCREW SELF-TAPPING HEX HEAD 4.5 MM DIAMETER 115 MM LENGTH
Type of DevicePLATE, FIXATION
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8403249
MDR Text Key138513269
Report Number0002648920-2019-00169
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K142579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00234712315
Device Lot Number61347127
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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