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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 7.5X80MM SOLID ENNOVATE IMPLANTS

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AESCULAP AG ENNOVATE POLYAX.SCREW 7.5X80MM SOLID ENNOVATE IMPLANTS Back to Search Results
Model Number SY149TS
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with sy149ts - ennovate polyax. Screw 7. 5x80mm solid. According to the complaint description, the breakage of the ennovate screw was noticed when, after several attempts, they failed to apply the blockade. There was no described patient harm. Additional information was not available. Additional patient information is not available. The adverse event / malfunction is filed under aag reference (b)(4).
 
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Brand NameENNOVATE POLYAX.SCREW 7.5X80MM SOLID
Type of DeviceENNOVATE IMPLANTS
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 Key11855984
MDR Text Key251740836
Report Number9610612-2021-00418
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeAR
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
Type of Report Initial,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSY149TS
Device Catalogue NumberSY149TS
Device Lot Number52468721
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2018
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: 05/20/2021 Patient Sequence Number: 1
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