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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG S4 ELEMENT POLYAXIAL SCREW 6.0X55MM IMPLANTS POSTERIOR STABILISATION

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AESCULAP AG S4 ELEMENT POLYAXIAL SCREW 6.0X55MM IMPLANTS POSTERIOR STABILISATION Back to Search Results
Model Number ST266T
Device Problem Unintended System Motion (1430)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: 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 ag that a s4 element polyaxial screw 6. 0x55mm (part # st266t) was used during a procedure performed on an unknown date. According to the complainant, the device disintegrated during surgery. During the operation, surgeon wanted to turn the head of the screw so that it was inserted into the patient and the screw "disintegrated", the inner sealing ring was loosened. The patient was not damaged, the surgeon had to remove the screw and use a new one. The complaint device was returned to the manufacturer for evaluation. An additional medical intervention was necessary. Additional information was not provided nor available. The adverse event is filed under aag reference (b)(4). Associated medwatch reports: 9610612-2021-00756 - 400526775, 9610612-2021-00758 - 400527068.
 
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Brand NameS4 ELEMENT POLYAXIAL SCREW 6.0X55MM
Type of DeviceIMPLANTS POSTERIOR STABILISATION
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 Key12920847
MDR Text Key281667128
Report Number9610612-2021-00758
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04046963739294
UDI-Public4046963739294
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K090657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberST266T
Device Catalogue NumberST266T
Device Lot Number52621830
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2021
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: 12/02/2021 Patient Sequence Number: 1
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