MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MON DRC, E BY E, 5.5 X 5.50,TI; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number	177492060
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: mni, kwp.(b)(4).The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 revision surgery to remove the connector that came loose from rod.Customer would like to have connector evaluated.Patient and procedure outcome were unknown.This report is for (1) monarch spine system end to end dual connector 5.5mm - 5.5mm.This is report 1 of 1 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.H3, h4, h6: a manufacturing record evaluation was performed for the finished device, product code: 177492060, lot: ti0974.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: september 30, 2020.Visual inspection: the device was received at us customer quality for investigation.A visual inspection noted damage to the distal ends of the two set screws.There was also damage to one of the threaded holes inside the body of the device.Scratches were noted on the device that were consistent with implant removal.Functional test: no mating device was returned so a definitive functional test cannot be performed.Dimensional inspection: a dimensional inspection was not performed due to the geometry of the complaint relevant areas of the device.Document/specification review: the current and manufactured documents were reviewed as part of the investigation.No design or manufacturing discrepancies were noted.Conclusion: the complaint is not confirmed for the received device as the mating rod was not returned and therefore the loose condition cannot be evaluated.The investigation found damage to the set screws and one of the set screw threaded holes, but without the mating rod it cannot be determined if this damage would prevent attachment of connector to the rod.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: MON DRC, E BY E, 5.5 X 5.50,TI
• 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: 12969718
• Report Number: 1526439-2021-02537
• Device Sequence Number: 4423675
• Product Code: MNH
• UDI-Device Identifier: 10705034063058
• UDI-Public: (01)10705034063058
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K024348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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: 177492060
• Device Catalogue Number: 177492060
• Device Lot Number: TI0974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2020
• 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: UNKNOWN RODS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown