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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE SET SCREW STERILE IMPLANTS POSTERIOR STABILISATI

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AESCULAP AG ENNOVATE SET SCREW STERILE IMPLANTS POSTERIOR STABILISATI Back to Search Results
Model Number SY001TS
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/13/2022
Event Type  malfunction  
Event Description
It was reported that there was an issue with sy001ts - ennovate set screw sterile. According to the complaint description, the screw is labelled incorrectly. There was no described patient harm. Additional information was not provided. Additional patient information is not available. The malfunction is filed under aag reference (b)(4).
 
Manufacturer Narrative
Investigation results: visual investigation: the received set screw is a s4 version (sw790t) with a ennovate (sy001ts) inscription. We made a visual inspection of the complained screw. It is clearly recognizable that the present screw is a sw790t and not a sy001ts as lasered on. The extract of the drawing of sy001ts shows the difference, also the 3-d graphics. The sw790t is shorter, has a different thread- profile and a hexagon- driver profile instead a torx profile. Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production. Review of the complaint history revealed that no similar complaints have been filed against products from this batch number. The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence) according to din en iso 14971 is still acceptable. Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the reported issue can be traced back to a manufacturing-related failure. A recall for the batch 52758014 was initiated. Based upon the investigations results a product safety case and a field safety corrective action were initiated.
 
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Brand NameENNOVATE SET SCREW STERILE
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
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key14986088
MDR Text Key302245887
Report Number9610612-2022-00192
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K180433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial
Report Date 07/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSY001TS
Device Catalogue NumberSY001TS
Device Lot Number52758014
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2022
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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