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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS SPINE SPINAL MOTION IMPLANTS SPINAL MOTION

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AESCULAP AG COLLECT.NO.QAS SPINE SPINAL MOTION IMPLANTS SPINAL MOTION Back to Search Results
Model Number AE-QAS-SP44
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Paresis (1998)
Event Date 10/05/2018
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: evaluation on-going. Investigation on-going. Additional information / investigation results will be provided in a supplemental report. Initial investigation findings: no sample received (ennovate screw). Batch history review: because there was neither a product name nor batch known, a device history review is not possible. Conclusion and rationale: the failure description refers to a misplacement of a screw.
 
Event Description
It was reported that a patient underwent a spinal revision surgery due to misplacement of an ennovate s1 screw. A (b)(6) patient underwent an initial spinal procedure on (b)(6) 2018. An s1 screw was placed. On (b)(6) 2018, she presented to the hospital with severe pain and was readmitted. A ct scan showed misplaced screw s1 left, and stenosis l5 left. Conservative therapy was initiated; however, it was unsuccessful. On an unknown date, the patient experienced paresis of the dorsal flexor of the left foot, kg 4/5. Revision surgery was performed on (b)(6) 2018. The screw at s1 left was removed; it was noted that the screw was discarded. Operative record, x-rays, and additional device information are expected.
 
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Brand NameCOLLECT.NO.QAS SPINE SPINAL MOTION
Type of DeviceIMPLANTS SPINAL MOTION
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 Key8090512
MDR Text Key127939130
Report Number9610612-2018-00500
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P120024
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 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberAE-QAS-SP44
Device Catalogue NumberAE-QAS-SP44
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date11/07/2018
Event Location No Information
Date Manufacturer Received10/23/2018
Was Device Evaluated by Manufacturer? Yes
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: 11/20/2018 Patient Sequence Number: 1
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