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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 3.5 MM DIAMETER 40 MM LENGTH PLATE, FIXATION

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ZIMMER MANUFACTURING B.V. CORTICAL BONE SCREW SELF-TAPPING HEX HEAD 3.5 MM DIAMETER 40 MM LENGTH PLATE, FIXATION Back to Search Results
Catalog Number 47234804035
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 12 mm length pn: 47234801235 ln: 63406688, cortical bone screw self-tapping hex head 3. 5 mm diameter 46 mm length pn: 47234804635 ln: 61214651. Foreign source: (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, 0001822565-2019-00664, 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. 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 40 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 Key8348440
Report Number0002648920-2019-00109
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 EXPIRATION Date02/07/2019
Device Catalogue Number47234804035
Device LOT Number61168845
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
Date Device Manufactured02/09/2009
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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