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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE MIS CURVED ROD 5.5X40MM POSTERIOR STABILIZATION ROD

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AESCULAP AG ENNOVATE MIS CURVED ROD 5.5X40MM POSTERIOR STABILIZATION ROD Back to Search Results
Model Number SY932TS
Device Problem Fracture (1260)
Patient Problem Pain (1994)
Event Date 11/16/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation is on going at manufacturing site. A supplemental report will be provided when additional information is available.
 
Event Description
It was reported that two days after being implanted, the patient heard a cracking sound and experienced mild back pain. There is breakage of the alif cage (at l5-s1) due to failure of the fixture (polyoaxial mechanism). Implants are still implanted, no parts have been removed to date. There is currently no information regarding further treatment of the patient. Involved components, listed as concomitant devices include: sy647ts / ennovate polyax. Screw 7. 5x60mm canulated / lot number: 52384209; sy001ts / ennovate set screw sterile / lot number: 52461667; sy001ts / ennovate set screw sterile / lot number: 52406268. Medwatch reports submitted for this patient include: 9610612-2018-00564 ; 9610612-2018-00572 (this report).
 
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Brand NameENNOVATE MIS CURVED ROD 5.5X40MM
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 Key8142105
MDR Text Key130059758
Report Number9610612-2018-00572
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
Type of Report Initial,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSY932TS
Device Catalogue NumberSY932TS
Device Lot Number52370777
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date12/10/2018
Device Age1 YR
Event Location No Information
Date Manufacturer Received12/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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