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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
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.

 
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Brand NameCORTICAL BONE SCREW SELF-TAPPING HEX HEAD 3.5 MM DIAMETER 12 MM LENGTH
Type of DevicePLATE, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key8348437
Report Number0001822565-2019-00664
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/08/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/18/2019 Patient Sequence Number: 1
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