MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXIAL SCREW 6 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179712640
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code kwp; kwq; mnh; mni; osh.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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
Device report from (b)(6) reports an event as follows: it was reported on an unknown date that the patient underwent for a removal surgery due to pseudarthrosis l4-5 and prolongation to s1.L5 screws were loose bilateral and removed.No new screws could be used because of the large hole in the pedicle.Prolongation to s1 and rod insertion and fixation l4-s1.The surgery was completed successfully without delay.There were no patient consequences.Concomitant device reported: unknown rods (part# unknown, lot# unknown, quantity unknown ), unknown setscrews (part# unknown, lot# unknown, quantity unknown ).This complaint involves two (2) devices.This report is for (1) si polyaxial screw 6 x 40mm.This report is 2 of 2 for (b)(4).
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.H6: investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot, lot # provided is not a valid number, therefore, the dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.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.
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.D4: udi updated.D11: additional concomitant device reported.H11/d4: the combination of the product code: 179712640and lot number: 179712640 doesn't exist in our 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.D4.

• Brand Name: SI POLYAXIAL SCREW 6 X 40MM
• 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
• MDR Report Key: 11148075
• Report Number: 1526439-2021-00129
• Device Sequence Number: 3494532
• Product Code: MAX
• UDI-Device Identifier: 10705034067728
• UDI-Public: 10705034067728
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2020

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: 179712640
• Device Catalogue Number: 179712640
• Device Lot Number: 179712640
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/20/2021; 02/23/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/08/2021; 03/09/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SI POLYAXL SCREW 6 X 40MM; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; SI POLYAXL SCREW 6 X 40MM; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR