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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS SPINE ANTERIOR STABILIS.; IMPLANTS/DISPOSABLES ANTERIOR
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AESCULAP AG COLLECT.NO.QAS SPINE ANTERIOR STABILIS.; IMPLANTS/DISPOSABLES ANTERIOR Back to Search Results
Device Problem Migration (4003)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Event Description
It was reported to aesculap inc., via the annual activl enhanced safety surveillance study (ess) covering a reporting period from 01feb2023 to 31dec2023, that an unknown activ l device was implanted on an unspecified date at the level l4-l5 using spike endplate.According to the complainant there was a supplemental fixation at index level 1.Reportedly the patient's neurological status worsened and there was a disability due to worsening back pain.The adverse event is filed under aic reference (b)(4).Associated medwatch reports: 2916714-2024-00065; 2916714-2024-00068.
 
Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
 
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Brand Name
COLLECT.NO.QAS SPINE ANTERIOR STABILIS.
Type of Device
IMPLANTS/DISPOSABLES ANTERIOR
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key18985652
MDR Text Key338690431
Report Number2916714-2024-00066
Device Sequence Number1
Product Code KWQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/27/2024
Distributor Facility Aware Date03/08/2024
Event Location Hospital
Date Report to Manufacturer03/08/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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