MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI HARD ROD 150MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	498.236
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional procodes: kwq, mni, mnh, nkb.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.A device history record review has been requested.(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 that on an unknown date, a pediatric patient underwent an unknown procedure using a universal spine system (uss) system rod.On an unknown postoperative date, the rod broke in the patient.Revision surgery is scheduled for (b)(6) 2019.There are no reports of serious/permanent damage.This report is for a 5.0mm titanium (ti) hard rod 150mm.This is report 1 of 1 for (b)(4).
Additional 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.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
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.Device history lot, part number 498.236, lot number: 9918893, date of manufacture: 11-07-2015, place of manufacture: brandywine plant.The device history record(s) showed that there were no nonconformances or issues during the manufacture of the product that would contribute to this complaint condition.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 HARD ROD 150MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8297144
• Report Number: 8030965-2019-60565
• Device Sequence Number: 16759930
• Product Code: KWP
• UDI-Device Identifier: 10705034789606
• UDI-Public: (01)10705034789606
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K994121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2019

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: 498.236
• Device Catalogue Number: 498.236
• Device Lot Number: 9918893
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 02/06/2019; 03/06/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 02/28/2019; 03/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention