MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXIAL SCREW 5.5 X 6 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179712645
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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.(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.
Event or Problem Description
It was reported that on (b)(6) 2021, a revision surgery was performed to extend the construct up.Upon opening, it was noticed that metallosis had occurred.The heads of the pedicle screws at t11 and t12 on the right had dislodged and broken off of the screws.It was also occurred with the left sacral screw.The previous construct was from t10-pelvis.This report is for one (1) si polyaxial screw 5.5 x 6 x 45mm.This is report 1 of 6 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: d4, d9 h3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.H11: corrected data: g1: physical manufacturer.
Additional Manufacturer Narrative
Product complaint # (b)(4).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: h3, h6: investigation summary.Investigation flow: damage.Visual inspection: the si polyaxl screw 6 x 45mm (p/n: 179712645, lot #: avlc9p) was returned and received at us cq.Upon visual inspection, it was observed that there were scratches and discoloration on the device but has no impact on the functionality of the device.No other issues were identified on the returned device.Device failure/defect is identified.Dimensional inspection: complaint relevant dimensional inspection cannot be performed due to the post-manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Complaint is not confirmed.Investigation conclusion the complaint could not be confirmed for the returned device, as no broken features were observed.No definitive root cause can be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 history lot part #: 179712645.Lot #: avlc9p.The dhr of product code: 179712645, lot: avlc9p was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 2sep 26, 2016.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: SI POLYAXIAL SCREW 5.5 X 6 X 45MM
• 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
• MDR Report Key: 12204953
• Report Number: 1526439-2021-01452
• Device Sequence Number: 5061840
• Product Code: NKB
• UDI-Device Identifier: 10705034067735
• UDI-Public: 10705034067735
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2021

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: 179712645
• Device Catalogue Number: 179712645
• Device Lot Number: AVLC9P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 07/16/2021; 08/10/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 07/22/2021; 08/13/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXP TI POLY SCREW 9MMX50MM; SI POLYAXL SCREW 6 X 45MM; SI POLYAXL SCREW 7 X 50MM; SI POLYAXL SCREW 7 X 50MM; SI POLYAXL SCREW 7 X 55MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR