MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP RESPONSE BANDLOC SPINAL FIXATION; BONE FIXATION CERCLAGE, SUBLAMINAR

Model Number 10-1102-1555

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is completed.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of complaint history determined that no further action is required as no trends were identified.

Event Description

A set screw disengaged from the band-loc device.Event was identified in post-operative x-ray.A revision surgery was not performed.

• Brand Name: RESPONSE BANDLOC SPINAL FIXATION
• Type of Device: BONE FIXATION CERCLAGE, SUBLAMINAR
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier dr; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier dr; warsaw, in
• Manufacturer Contact: kriss anderson ; 2850 frontier dr; warsaw, in ; 2686379
• MDR Report Key: 9690263
• MDR Text Key: 190692844
• Report Number: 3006460162-2019-00094
• Device Sequence Number: 1
• Product Code: OWI
• UDI-Device Identifier: 00841132150627
• UDI-Public: 00841132150627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-1102-1555
• Device Lot Number: 181675
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2019
• Initial Date FDA Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 10 YR