MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 6.0MM TI CURVED SOFT ROD 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.620.140S

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional procodes; mni, mnh, kwp, kwq.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2020 a tlif (transforaminal lumbar interbody fusion) in l4-l5 was performed to treat spinal canal stenosis without surgical delay.The uss ii polyaxial system and proti t-pal cage were applied.After the screws were inserted, decompression was applied.The cage was inserted from the right.A 45mm rod was inserted on the right, a sleeve and a nut were deployed, and compression and final fixation were applied.The 40mm rod was inserted on the left, a sleeve and a nut were deployed, and compression and final fixation were applied.A transverse connector was not deployed.On (b)(6) 2020 post operative x-rays showed that the rod on the left had come off the l5 screw.Also, the rod had rotated inward together with the l4 screw.The patient had felt some discomfort since he underwent the initial procedure.A revision will be scheduled.This is report 2 of 5 for (b)(4).

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.H6 patient codes: code 3191 used to capture surgical intervention.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.

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.Visual inspection: the inspection has shown that there are some clearly visible stress marks at the received rod.Functional test: the functionality of the devices with respect to the complaint condition has been verified reinspecting the dimensional features at the manufacturing site which determine the functionality of the involved items: no functionality defect or deficiency identified.Complaint condition replication cannot be confirmed because the affected item has been returned disassembled in its components.Dimensional inspection: a full re-inspection of all relevant features according to the corresponding drawings was made at the manufacturing site and no manufacturing related issue could be detected.The measurable features have been found conforming to manufacturing specifications, for details see attached files.Drawing/specification review: the corresponding drawings were reviewed as part of the manufacturing evaluation to verify the relevant dimensions of the received part.The uss ii polyaxial surgical technique 036.000.216 was reviewed and following note can be mentioned related to this complaint: note: it is necessary to apply a tightening moment of 12 nm to secure the polyaxial screw heads tightly.To achieve this, the torque-limiting handle 12 nm (03.602.042) may be used instead of the socket wrench.Investigation conclusion: the complaint condition that x-rays showed that the rod on the left had come off the l5 screw and that the rod had rotated inward together with the l4 screw cannot be confirmed without the mentioned x-rays.Nevertheless is the complaint rated as confirmed due to the visible damages at the received devices.During the performed evaluation no manufacturing related issue could be detected, all relevant features were re-inspected and were according to the specification.The visual inspection has shown that the anodized layer is worn away at all damages, which indicates that they were caused post-manufacturing.Afterwards it cannot be defined if the damages occurred during the insertion, in-situ or extraction.Based on the provided limited information it is not possible to determine the cause of this occurrence.The visible marks indicate that the devices were exposed to high loads, but it cannot be defined it these loads occurred intra-operative or post-operative.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history part number: 04.620.140s, synthes lot number: 7630191, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 21.Oct.2011, expiry date: 01.Oct.2021.Device was first manufactured unsterile under the lot 7591784 in mezzovico and sterilized afterwards.As this complaint is neither packaging nor sterilization related only the manufacturing documents of the unsterile device 04.620.140 with lot 7591784 were reviewed: part: 04.620.140 , lot: 7591784, manufacturing site: mezzovico, release to warehouse date: 12.Sep.2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 6.0MM TI CURVED SOFT ROD 40MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10294736
• MDR Text Key: 199661687
• Report Number: 8030965-2020-04973
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 04.620.140S
• Device Lot Number: 7630191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Date Manufacturer Received: 08/24/2020
• Patient Sequence Number: 1
• Treatment: USS-II NUT TAN GREEN; USS-II POLYAXIAL 3D-HEAD F/R Ø6 TAN GREE; USS-II POLYAXIAL SLEEVE F/R Ø6 TAN GREEN; USS-II-POLYAXIAL PEDICSCR Ø7 L45 TAN GRE
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR