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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 6.5X35MM CANULATED SPINE SURGERY

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AESCULAP AG ENNOVATE POLYAX.SCREW 6.5X35MM CANULATED SPINE SURGERY Back to Search Results
Model Number SY001TS
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  malfunction  
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 (b)(4) that two (2) ennovate set screws (part # sy001ts) were used during a procedure performed on (b)(6) 2021. According to the complainant, the set screw (ref. Mdr id 9610612-2021-00531) was damaged while fastening with a parsuader. A new ennovate set screw was used, but the same issue recurred. The procedure was completed using a third screw. The complaint device was returned to the manufacturer for evaluation. No patient complications were reported as a result of this event. Additional information has not been made available. The malfunction is filed under aag reference (b)(4). Associated medwatch-reports: 9610612-2021-00531_mdr (b)(4). Involved components: sy632ts - ennovate polyax. Screw 6. 5x35mm canulated - 52534620.
 
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Brand NameENNOVATE POLYAX.SCREW 6.5X35MM CANULATED
Type of DeviceSPINE SURGERY
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 Key12284280
MDR Text Key265603496
Report Number9610612-2021-00532
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04046964989728
UDI-Public4046964989728
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K180433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSY001TS
Device Catalogue NumberSY001TS
Device Lot Number52663512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2020
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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