MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP RESPONSE 5.5/6.0 SPINE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Reference: (b)(4).Concomitant medical products: item number: unknown, unknown 5.5/6.0 spine rod, lot number: unknown.Customer has indicated that the product will not be returned to orthopediatrics for investigation as it remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 3006460612-2019-00082.

Event Description

It has been reported that approximately three years following the placement of a response spinal construct, it was discovered via x-ray, that both rods had fractured.A revision surgery has been scheduled.No additional patient consequences were reported.

Manufacturer Narrative

The follow is being submitted to relay additional information.Corrected: a4: 120 kg.Updated: b4: date of report: (b)(6) 2020.D1: brand name: response 5.5/6.0 spine system.D4: item number: 00-1003-6001 lot number: 35340-d udi: (b)(4).D7: explanted date: (b)(6) 2020.D10: device available for evaluation: yes.H4: manufacture date: 21 jul 2015.H5: labeled for single use.H6: updated method codes: 3331, 4109 and 10.H6: updated results codes: 3252.H6: updated conclusion codes: 4315.Complaint sample was returned for evaluation.Reported event was confirmed.Investigation of the dhr did not reveal any process deviations or indications of manufacturing variations that would contribute to the observed failure mode.Risk management file review was deemed appropriate.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 3006460612-2019-00082 and 3006460612-2019-00082-001.

• Brand Name: RESPONSE 5.5/6.0 SPINE SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• MDR Report Key: 9714495
• MDR Text Key: 185758504
• Report Number: 3006460162-2019-00083
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• PMA/PMN Number: K150600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-1003-6001
• Device Lot Number: 35340-D
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Weight: 120