MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 3.5X16MM 3.5 AND 4.0; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	1020-35-116S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during a posterior cervical decompression and fusion (c3-c6) treating opll, the self retaining inserter was stuck and could not pull out from the set screw when the c6 screw was inserted.When the inserter was pulled manually, the rod, set screw, and screw came off entirely while remaining attached.The surgeon proceeded with the procedure by inserting a new screw with an increased size as well as a new rod and set screw.The procedure was successfully completed with a surgical delay of thirty (30) minutes.The patient outcome was reported as stable.There is no further information available.This report is for one (1) symphony oct system polyaxial screw diameter 4.0 rod, 3.5x16mm 3.5 and 4.0.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Additional procode: nkg.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 history lot: the dhr of product code: 102035116s, lot : 279998, was electronically reviewed and no non-conformance were observed during the manufacturing process.The product was released on: may 27, 2020.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: SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 3.5X16MM 3.5 AND 4.0
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 13019148
• Report Number: 1526439-2021-02574
• Device Sequence Number: 4963471
• Product Code: KWP
• UDI-Device Identifier: 10705034524382
• UDI-Public: 10705034524382
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 1020-35-116S
• Device Catalogue Number: 102035116S
• Device Lot Number: 279998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2020
• 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: SET SCREW; TI 3.5X120 STR ROD; X15 SELF RETAINING INSERTER
• Patient Sex: Unknown