• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM RESPONSE 5.5/6.0 SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ORTHOPEDIATRICS, CORP 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM RESPONSE 5.5/6.0 SYSTEM Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Pain (1994)
Event Date 02/18/2020
Event Type  Injury  
Manufacturer Narrative

Reference: (b)(4). Concomitant medical products: 5. 5/ 6. 0 uniaxial pedicle screw 6. 0mm x 40mm, item number: 00-1300-0640, lot number: unknown. Complaint sample was not returned for evaluation, scrapped by the hospital. Reported event was confirmed by review of customer submitted radiographs and ct films. Dhr review was unable to be performed as the lot number of the involved device is unknown. Risk management file review was deemed appropriate. Review of the complaint history determined that no further action is required as there were no trends identified. Root cause was unable to be determined.

 
Event Description

It was reported the patient presented complaining of pain at the lower end of the implanted spinal construct. Radiographs and ct scan showed a lack of fusion at the lower level. Two pedicle screws were found to be broken and a revision surgery was required.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM
Type of DeviceRESPONSE 5.5/6.0 SYSTEM
Manufacturer (Section D)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw, in
Manufacturer (Section G)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw, in
Manufacturer Contact
leigh jessop
2850 frontier drive
warsaw, in 
2670872
MDR Report Key9779731
MDR Text Key186558640
Report Number3006460162-2020-00039
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 03/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00-1300-0640
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/03/2020 Patient Sequence Number: 1
-
-