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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC RESPONSE LARGE SET SCREW PEDICLE SCREW SPINAL SYSTEM

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ORTHOPEDIATRICS, INC RESPONSE LARGE SET SCREW PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Pain (1994)
Event Date 03/25/2019
Event Type  Injury  
Manufacturer Narrative

Reference: (b)(4). 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.

 
Event Description

It was reported that following a posterior fusion surgery, the patient experienced back pain and clicking. It was discovered during the revision procedure that a set screw was loose. No additional patient consequences were reported.

 
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Brand NameRESPONSE LARGE SET SCREW
Type of DevicePEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw IN 46582
Manufacturer (Section G)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw IN 46582
Manufacturer Contact
leigh jessop
2850 frontier drive
warsaw, IN 46582
5742670872
MDR Report Key8571189
MDR Text Key143754574
Report Number3006460162-2019-00015
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK150600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial
Report Date 05/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00-1003-4001
Device LOT NumberM69067-B
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 Received04/01/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/16/2016
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: 05/01/2019 Patient Sequence Number: 1
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