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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP RESPONSE 4.5/5.0 REDUCTION TOWER

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ORTHOPEDIATRICS, CORP RESPONSE 4.5/5.0 REDUCTION TOWER Back to Search Results
Model Number 01-1600-9081
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/25/2020
Event Type  malfunction  
Manufacturer Narrative
Customer has indicated that the product is in process of being returned to orthopediatrics for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. (b)(4).
 
Event Description
It was reported that while securing the rod reduction tower to a 5. 0x35 polyaxial 4. 5/5. 0 screw, the connecting side of the tower broke. Two small pieces of metal were removed from the surgical site, and the tower was no longer functional. We were able to use the second tower in the set to continue the procedure without delay. No adverse events have been reported as a result of the malfunction.
 
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Brand NameRESPONSE 4.5/5.0 REDUCTION TOWER
Type of DeviceREDUCTION TOWER
Manufacturer (Section D)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw, in
Manufacturer (Section G)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw, in
Manufacturer Contact
kriss anderson
2850 frontier drive
warsaw, in 
2686379
MDR Report Key10307788
MDR Text Key199889600
Report Number3006460162-2020-00083
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181390
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 07/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number01-1600-9081
Device Catalogue Number01-1600-9081
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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