• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE CURVED ROD 5.5X45MM IMPLANTS POSTERIOR STABILISATI

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AESCULAP AG ENNOVATE CURVED ROD 5.5X45MM IMPLANTS POSTERIOR STABILISATI Back to Search Results
Model Number SY433TS
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Paresis (1998); Patient Problem/Medical Problem (2688)
Event Date 03/26/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Investigation: no product at hand. Batch history review: because the problem is not product related, a batch history review is not necessary. Conclusion and root cause: the root cause of the problem is most probably usage and/or patient related. If additional information is received a follow up report will be submitted.
 
Event Description
It was reported foot extensor paresis 4 weeks post operatively. The reporter indicated on (b)(6) 2019 the patient came to the outpatient hospital due to increasing right foot extensor paresis 4 weeks postoperatively. The patient was admitted for further neurological intervention, mrt and ct scan. The results of the mrt and ct showed no evidence of a herniated disc or screw failure. Additional information has been requested, however, not yet received. Associated medwatches: 9610612-2019-00239, 9610612-2019-00240, 9610612-2019-00241, (this report), 9610612-2019-00243, 9610612-2019-00244.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENNOVATE CURVED ROD 5.5X45MM
Type of DeviceIMPLANTS POSTERIOR STABILISATI
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 Key8541156
MDR Text Key142799593
Report Number9610612-2019-00242
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 company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSY433TS
Device Catalogue NumberSY433TS
Device Lot Number52472538
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date04/01/2019
Event Location No Information
Date Manufacturer Received03/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/23/2019 Patient Sequence Number: 1
-
-