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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP, INC. CASPAR DISTRACTION PINS 14MM
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AESCULAP, INC. CASPAR DISTRACTION PINS 14MM Back to Search Results
Model Number FF904SB
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)
Event Date 12/18/2018
Event Type  malfunction  
Event Description
When surgeon was attempting to remove the distraction pins, the pins broke off flush with the bone.The surgeon decided to leave the fragmented part of the pins in the bone because trying to remove them would cause more harm than leaving them in.The areas were covered with bone wax and no metal left exposed.The distraction pins part numbers listed below.Ref# ff904sb, lot # 52434217, exp 06/30/2023; ref# ff904sb, lot# 52436966, exp 07/31/2023.The surgery time was extended due to the attempts to remove the fractured pins.
 
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Brand Name
CASPAR DISTRACTION PINS 14MM
Type of Device
CASPAR DISTRACTION PIN
Manufacturer (Section D)
AESCULAP, INC.
hazelwood MO 63042
MDR Report Key8260675
MDR Text Key133860651
Report Number8260675
Device Sequence Number1
Product Code LXH
UDI-Device Identifier00408653364305
UDI-Public0408653364305
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFF904SB
Device Catalogue NumberFF904SB
Device Lot NumberEVENT DESCRIPTION
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/21/2018
Distributor Facility Aware Date12/18/2018
Event Location Hospital
Date Report to Manufacturer12/21/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age49 YR
Patient Weight95
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