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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE MIS STRAIGHT ROD 5.5X300MM POSTERIOR STABILIZATION ROD

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AESCULAP AG ENNOVATE MIS STRAIGHT ROD 5.5X300MM POSTERIOR STABILIZATION ROD Back to Search Results
Model Number SY921TS
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 11/19/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Investigation: on-going at manufacturing site, supplemental report will be submitted when additional information is available.
 
Event Description
It was reported that two s4 straight rods broke; one on each side of the construct, 4 months, 24 days after implantation. Additional information has not been provided at the date of this report; if additional information is received, a supplemental report will be submitted. Medwatch reports submitted for this patient include: 9610612-2018-00569.
 
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Brand NameENNOVATE MIS STRAIGHT ROD 5.5X300MM
Type of DevicePOSTERIOR STABILIZATION ROD
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key8142088
MDR Text Key129613934
Report Number9610612-2018-00570
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K180433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSY921TS
Device Catalogue NumberSY921TS
Device Lot Number52372598
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date12/07/2018
Device Age11 MO
Event Location No Information
Date Manufacturer Received12/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2017
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: 12/07/2018 Patient Sequence Number: 1
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