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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH 5.5 TI CORT FIX 6X40MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH 5.5 TI CORT FIX 6X40MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 186731640
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Injury (2348)
Event Date 08/18/2020
Event Type  Injury  
Manufacturer Narrative
Additional device product codes: kwp, mni, kwq, mnh. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during a spinal fusion procedure in c2-th4 to treat the dropped head, the surgeon instructed the nurse to prepare screws, but she mistakenly prepared longer screws. Those screws were inserted and later replaced with correct screws. The procedure was delayed for thirty (30) minutes. No further information is available. This report is for one (1) 5. 5 ti cort fix 6x40mm. This is report 1 of 2 for (b)(4).
 
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Brand Name5.5 TI CORT FIX 6X40MM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INT SPINE
chemin blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10532288
MDR Text Key207137732
Report Number1526439-2020-01677
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034351827
UDI-Public(01)10705034351827
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K110216
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number186731640
Device Catalogue Number186731640
Device Lot Number142978
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/05/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/14/2020 Patient Sequence Number: 1
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