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

Model Number	10-1102-1555
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: BONE FIXATION CERCLAGE, SUBLAMINAR
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier dr; warsaw, in
• MDR Report Key: 9690263
• Report Number: 3006460162-2019-00094
• Device Sequence Number: 11618561
• Product Code: OWI
• UDI-Device Identifier: 00841132150627
• UDI-Public: 00841132150627
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 10-1102-1555
• Device Lot Number: 181675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2019
• Initial Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR