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U.S. Department of Health and Human Services

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

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ORTHOPEDIATRICS, INC RESPONSE UNIAXIAL PEDICLE SCREW PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative

Reference: (b)(4). Complaint sample was evaluated and the reported event was confirmed. Visual inspection confirmed that the screw fractured. Investigation of the dhr did not reveal any process deviations or indications of manufacturing variations that would contribute to the observed failure mode. The screw was made to specification, there had been no recent design changes to the screw shaft, and there are no other complaints related to this part number. The root cause was unable to be determined. "loss of fixation or implant breakage attributable to delayed or non-union" is a known adverse effect stated in the device ifu. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Orthopediatrics will continue to monitor for trends.

 
Event Description

It was reported that following the placement of a response spine construct, a screw was found to be fractured at a one-year follow-up. The surgeon believes that pseudarthrosis caused the fracture of the screw. The patient underwent a revision procedure to replace the fractured screw. No additional patient consequences were reported.

 
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Brand NameRESPONSE UNIAXIAL PEDICLE 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
5172670872
MDR Report Key8016746
MDR Text Key125382306
Report Number3006460162-2018-00069
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial
Report Date 10/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00-1300-3650
Device LOT Number041818-E
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/08/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/29/2018
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: 10/29/2018 Patient Sequence Number: 1
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