MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI SCHANZ SCREW WITH DUAL CORE 45MM THREAD/190MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 496.713S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.Date of event is unknown.Additional procodes: mni, mnh, kwp, kwo.Device was not explanted.Reporter email address is unavailable.Please note, this dhr review is for sterilization procedure only: part no.: 496.713s.Lot no.: l384524.Manufacturing location: (b)(6).Supplier: (b)(6).Release to warehouse date: 19.Apr.2017.Expiry date: 01.Apr.2027.No nonconformace records (ncr) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Non-sterile 496.713 / 9090760 was manufactured in (b)(4).Release to warehouse date: 05.Aug.2014.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017, a surgery for burst fracture at l4 was performed using the universal spine system (uss) fracture system.The fixed area was l3 ¿ l5.On (b)(6) 2018, the breakage of the reported screw was confirmed at l3 under the x-ray, and non-union was also observed.It is unknown when the breakage happened.Patient status is unknown.This report is for a 5.0mm ti schanz screw with dual core 45mm thread/190mm.This is report 1 of 1 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.Additional narrative: udi.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: 5.0MM TI SCHANZ SCREW WITH DUAL CORE 45MM THREAD/190MM
• 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: 7506158
• MDR Text Key: 107970671
• Report Number: 8030965-2018-53684
• Device Sequence Number: 1
• Product Code: NKB
• 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: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 496.713S
• Device Lot Number: L384524
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR