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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH SINGLE-INNER SETSCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH SINGLE-INNER SETSCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 179702000
Device Problem Device Slipped (1584)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/17/2022
Event Type  Injury  
Manufacturer Narrative
Additional procodes: kwp, kwq, mnh, mni, osh. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Date of concomitant therapy is (b)(6) 2022. Reporter is a synthes employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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. (b)(4). 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 (b)(6) reports an event as follows: it was reported that patient underwent revision surgery on (b)(6) 2022, due to a migrated rod. The surgeon plans to replace screw, rod, and setscrews. The setscrew on the l3 left had thoroughly come off. The setscrew on the l3 right was loose. The rods had come off the lesion. The screws on both sides (had been secured in the lesion. The setscrews, the rods, and the screws were replaced without issue. Patient originally underwent a primary plif procedure (l3/4) on (b)(6) 2022. Postoperative x-rays showed no issue. On (b)(6) 2022, patient was x-rayed again, and images confirmed that a rod had come off the lesion while setscrews had been tightened in place. This report is for a single-inner setscrew. This is report 2 of 4 for (b)(4).
 
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Brand NameSINGLE-INNER SETSCREW
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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
SZ
Manufacturer Contact
kate karberg
chemin-blanc 38
le locle 
SZ  
3035526892
MDR Report Key14696907
MDR Text Key294036336
Report Number1526439-2022-00850
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034064307
UDI-Public(01)10705034064307
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160904
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number179702000
Device Catalogue Number179702000
Device Lot Number306735
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/15/2022 Patient Sequence Number: 1
Treatment
5.5 TI CORT FIX 7X50MM; MOSS MIAMI ROD 5.5X50MM TI; SINGLE-INNER SETSCREW
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