MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 6X45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186731645
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: event year is reported as 2021; however exact date of asd development is unknown.Additional device product codes: kwq; mnh; kwp; mni.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: a manufacturing record evaluation was performed for the finished device product code: 186731645, lot number: atmcn3.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 14.10.2015 qty: 96.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2016, the patient underwent a primary posterior lumbar interbody fusion (plif) (l4-5) procedure.On (b)(6) 2021, it was reported that the patient had suffered from asd between l3-4.The patient was scheduled to undergo a revision procedure (l3-4 plif extension) on (b)(6) 2021.No further information is available.This report is for one (1) viper system cortical fix polyaxial screw 5.5 6 x 45mm.This is report 6 of 12 for complaint (b)(4).
Additional Manufacturer Narrative
Additional narrative: event year is reported as 2021; however exact date of asd development is unknown.Additional device product codes: kwq; mnh; kwp; mni.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: a manufacturing record evaluation was performed for the finished device product code: 186731645, lot number: atmcn3.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 14.10.2015 qty: (b)(4).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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2016, the patient underwent a primary posterior lumbar interbody fusion (plif) (l4-5) procedure.On (b)(6) 2021, it was reported that the patient had suffered from asd between l3-4.The patient was scheduled to undergo a revision procedure (l3-4 plif extension) on (b)(6) 2021.No further information is available.This report is for one (1) viper system cortical fix polyaxial screw 5.5 6 x 45mm.This is report 6 of 12 for complaint (b)(4).

• Brand Name: 5.5 TI CORT FIX 6X45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13177233
• Report Number: 1526439-2022-00035
• Device Sequence Number: 14592950
• Product Code: NKB
• UDI-Device Identifier: 10705034351834
• UDI-Public: (01)10705034351834
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Model Number: 186731645
• Device Catalogue Number: 186731645
• Device Lot Number: ATMCN3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2015
• 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: 5.5 TI CORT FIX 6X45MM; 5.5 TI CORT FIX 6X45MM; 5.5 TI CORT FIX 6X45MM; CONCORDE BUL PAR 9X8X23; CONCORDE BUL PAR 9X8X23; MMSI ROD, 5.5 X 40MM, TI; MMSI ROD, 5.5 X 40MM, TI; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown