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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

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ORTHOPEDIATRICS, CORP RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS Back to Search Results
Model Number N/A
Device Problem Naturally Worn (2988)
Patient Problem No Information (3190)
Event Date 11/06/2019
Event Type  Injury  
Manufacturer Narrative

Reference: (b)(4). Concomitant product: item number: 00-1003-4001, response large set screw, lot number: m56976-b, item number: 00-1003-4001, response large set screw, lot number: m55906-a, item number: 00-1300-0745, response 5. 5/6. 0 uniaxial pedicle screw 7. 0mm x 45mm, lot number: 041824-e, item number: unknown, unknown response 6. 0 cocr rod, lot number: unknown, item number: unknown, unknown response 6. 0 cocr rod, lot number: unknown. Multiple mdr reports were filed for this event, please see associated reports: 3006460612-2019-00084, 3006460612-2019-00085, and 3006460612-2019-00087.

 
Event Description

It has been reported that following the placement of a response spinal construct, the patient underwent a revision due to rod fracture and disengagement. During the revision it was noted that two pedicle screws were replaced due to wear. No additional patient consequences were reported.

 
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Brand NameRESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM
Type of DevicePEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
Manufacturer (Section D)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw, in
Manufacturer (Section G)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw, in
Manufacturer Contact
leigh jessop
2850 frontier drive
warsaw, in 
2670872
MDR Report Key9756062
MDR Text Key185788306
Report Number3006460162-2019-00086
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,Followup
Report Date 02/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00-1300-0745
Device LOT Number042938-E
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 Received11/20/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/05/2015
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: 02/26/2020 Patient Sequence Number: 1
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