MAUDE Adverse Event Report: TI MATRIXRIB PRE-CONTOURED PL 16 HOLES FOR LEFT RIBS 4 & 5; PLATE, FIXATION, BONE

Model Number	04.501.003
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2021, the patient underwent removal procedure due to the screws being placed improperly and the plate palpable to the skin.The patient is experiencing pain.This complaint involves seven (7) devices.This report is for one (1)ti matrixrib pre-contoured pl 16 holes for left ribs 4 & 5.This is report 1 of 7 for (b)(4).

• Brand Name: TI MATRIXRIB PRE-CONTOURED PL 16 HOLES FOR LEFT RIBS 4 & 5
• Common Device Name: PLATE, FIXATION, BONE
• MDR Report Key: 12752100
• Report Number: 2939274-2021-06484
• Device Sequence Number: 9230762
• Product Code: HRS
• UDI-Device Identifier: 10887587016962
• UDI-Public: (01)10887587016962
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.501.003
• Device Catalogue Number: 04.501.003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: MATRIXRIB
• Outcome Attributed to Adverse Event: Required Intervention