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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 3.5 MM DIAMETER 12 MM LENGTH; PLATE, FIXATION
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ZIMMER BIOMET, INC. CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 3.5 MM DIAMETER 12 MM LENGTH; PLATE, FIXATION Back to Search Results
Catalog Number 47234801235
Device Problem Unintended Movement (3026)
Patient Problem Unspecified Infection (1930)
Event Date 10/16/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: distal lateral fibular plate left 6 holes 106 mm length, pn: 47235701806, ln: 63550687; 2.7 mm locking screw 14 mm length, pn: 47482801402, ln: 63671062; 2.7 mm locking screw 16 mm length, pn: 47482801602, ln: 63869781; 2.7 mm locking screw 12 mm length, pn: 47482801202, ln: 63861780; 2.7mm locking screw 12mm long, pn: unk, ln: 62348896; 2.7 mm locking screw 18 mm length, pn: 47482801802, ln: 63861772; cortical bone screw self-tapping hex head 3.5 mm diameter 18 mm length, pn: 47234801835, ln: 63098016; cortical bone screw self-tapping hex head 3.5 mm diameter 12 mm length, pn: 47234801235, ln: 63406688; cortical bone screw self-tapping hex head 3.5 mm diameter 40 mm length, pn: 47234804035, ln: 61168845; cortical bone screw self-tapping hex head 3.5 mm diameter 46 mm length, pn: 47234804635, ln: 61214651.Report source: foreign - (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00655, 0001822565-2019-00656, 0001822565-2019-00657, 0001822565-2019-00658, 0001822565-2019-00659, 0001822565-2019-00660, 0001822565-2019-00662, 0001822565-2019-00663, 0002648920-2019-00109, 0002648920-2019-00108.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by mfr? product not returned.
 
Event Description
It was reported that the patient underwent a revision due to screw backing out and alleged infection.However, there was no growth from three samples.
 
Manufacturer Narrative
It was determined this event was submitted under the incorrect manufacturer number.Please void this submission and reference 0002648920 - 2019 - 00740.
 
Event Description
It was determined this event was submitted under the incorrect manufacturer number.Please void this submission and refrence 0002648920 - 2019 - 00740.
 
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Brand Name
CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 3.5 MM DIAMETER 12 MM LENGTH
Type of Device
PLATE, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8348437
MDR Text Key136465227
Report Number0001822565-2019-00664
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
PMA/PMN Number
K111447
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number47234801235
Device Lot Number63406688
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2019
Was the Report Sent to FDA? No
Date Manufacturer Received10/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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