MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI POLYAXIAL HEAD FOR USS POLYAXIAL; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.607.402

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional product codes: mni, mnh, kwp, kwq.(b)(4).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.

Event Description

Device report from synthes (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent a spinal fusion procedure, an adjustment on level 2 due to hypermobility and nerve root compression.The patient had previous operations on levels 3, 4 & 5 with uss polyaxial cement augmentation spondylodese on an unknown date.So all the screws were explanted and completed the surgery by switching into a pedicle screw system.There was a 120 minutes surgical delay.It was unknown if there were fragments generated from the broken devices.It was unknown if there were adverse event to the patient reported.The complaint involves 56 devices.Due to a limit of impacted products per complaint, this complaint will be captured under 6 separate complaints as listed below: (b)(4).These complaints capture the post-op event that involved the fifty-six (56) polyaxial screws that were explanted due to hypermobility and nerve root compression and switched to a pedicle screw system, while, related complaint (b)(4) captures the intra-op events that involved the broken screws during tightening of the nut.This report is for one (1) ti polyaxial head for uss polyaxial.This is report 5 of 10 for complaint (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.H3, h4, h6: a device history record (dhr) review was conducted: part: 04.607.402 , lot: 3l93948 , manufacturing site: mezzovico , release to warehouse date: 22 march 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was conducted.Visual inspection: the visual inspection found no product issues that could have contributed to the clinical finding summary: this complaint was entered to capture the revision surgery due to hypermobility and nerve root compression.No product issues that could have contributed to this clinical finding were found.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: TI POLYAXIAL HEAD FOR USS POLYAXIAL
• 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: 8728142
• MDR Text Key: 148992646
• Report Number: 8030965-2019-65610
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819186361
• UDI-Public: (01)07611819186361
• Combination Product (y/n): N
• PMA/PMN Number: K082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.607.402
• Device Lot Number: 3L93948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Date Manufacturer Received: 07/05/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR