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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC RESPONSE SPINE 5.5, SET SCREW, SMALL PEDICLE SCREW SPINAL SYSTEM

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ORTHOPEDIATRICS, INC RESPONSE SPINE 5.5, SET SCREW, SMALL PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Concomitant product: item: 00-1300-5028, fixed cross connector, 28mm, lot: unknown. Reported event was unable to be confirmed due to limited information received from the customer. Dhr review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined.

 
Event Description

It was reported that during the placement of a response spinal construct, a small set screw sheered off and was left in the patient. No adverse events have been reported as a result of the malfunction.

 
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Brand NameRESPONSE SPINE 5.5, SET SCREW, SMALL
Type of DevicePEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
ORTHOPEDIATRICS, INC
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 Key9742964
MDR Text Key190697644
Report Number3006460162-2019-00041
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK160466
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 08/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00-1003-3012
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
Date Manufacturer Received07/04/2019
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

Patient TREATMENT DATA
Date Received: 02/23/2020 Patient Sequence Number: 1
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