MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD, STRAIGHT (WITH HEX ENDS) 6.35 X 600MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179978600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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 rods were broken during reverse logistics audit of returned device at (b)(4).There was no patient involvement and no additional information is available.This report is for one (1) rod, straight (with hex ends) 6.35 x 600mm.This is report 4 of 13 for (b)(4).

• Brand Name: ROD, STRAIGHT (WITH HEX ENDS) 6.35 X 600MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12815514
• Report Number: 1526439-2021-02413
• Device Sequence Number: 4629805
• Product Code: NKB
• UDI-Device Identifier: 10705034092355
• UDI-Public: 10705034092355
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K090230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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: 179978600
• Device Catalogue Number: 179978600
• Device Lot Number: TBGJD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXP 6.35 COCR ROD W/HEX ENDS 6.; ROD, STR, TI, 600MM (HX END).; ROD, STR, TI, 600MM (HX END).; ROD, STR, TI, 600MM (HX END).; ROD, STR, TI, 600MM (HX END).; ROD, STR, TI, 600MM (HX END).; ROD, STR, TI, 600MM (HX END).; ROD, STR, TI, 600MM (HX END).; VIPER2 STRAIGHT ROD480MM, COCR.; VIPER2 STRAIGHT ROD480MM, COCR.
• Patient Sex: Unknown