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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  
Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
 
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: 2916714-2024-00066; 2916714-2024-00065.
 
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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 Key18985658
MDR Text Key338690478
Report Number2916714-2024-00068
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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