MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER2 LORDOTIC ROD-40MM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number	186788040S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: additional product code: kwp, mni, kwq, nkb, osh.Complainant part is not expected to be returned for manufacturer review/investigation.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, customer contacted j&j for material composition of matrix & t-pal spinal system because she experiences high levels of pain in her back since she received the implants.Also, high levels of mercury was reported in her blood.This report is for one (1) viper2 lordotic rod-40mm.This is report 4 of 10 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h4: device history: a manufacturing record evaluation was performed for the finished device, product code: 186788040s, lot number: tbwkf.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 30.10.2018, qty: (b)(4).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.

• Brand Name: VIPER2 LORDOTIC ROD-40MM
• Common Device Name: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• 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: 13689318
• Report Number: 1526439-2022-00347
• Device Sequence Number: 5110889
• Product Code: MNH
• UDI-Device Identifier: 10705034238210
• UDI-Public: (01)10705034238210
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 186788040S
• Device Catalogue Number: 186788040S
• Device Lot Number: TBWKF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2018
• 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: MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS TI CFX FEN POLY 6X45; MIS TI CFX FEN POLY 6X45; MIS TI CFX FEN POLY 6X45; MIS TI CFX FEN POLY 6X45; VIPER2 LORDOTIC ROD-40MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown