MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH IMPLANT HOLDER; GUIDE

Catalog Number	389.204
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is company representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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 synthes reports an event in (b)(6) as follows: it was reported on an unknown date that during a spine procedure it was discovered that the synex cage holder was broken.This is a crucial instrument for 80% of the corpectomy procedure.The procedure was delayed 90 minutes and surgeon had to use multiple forceps which did not provide stability , so closed to spinal cord.The procedure was completed successfully.The patient outcome was unstable.This complaint involves one (1) device.This is report 1 of 1 for (b)(4).
Event or Problem Description
Device report from synthes reports an event in south africa as follows: it was reported on (b)(6) 2020, that during a spine procedure it was discovered that the synex cage holder was broken.This is a crucial instrument for 80% of the corpectomy procedure.The procedure was delayed 90 minutes and surgeon had to use multiple forceps which did not provide stability , so closed to spinal cord.The procedure was completed successfully.The patient outcome was unstable.This complaint involves one (1) device.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.

• Brand Name: IMPLANT HOLDER
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9964405
• Report Number: 8030965-2020-02872
• Device Sequence Number: 11343012
• Product Code: FZX
• UDI-Device Identifier: 07611819108998
• UDI-Public: (01)07611819108998
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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 Catalogue Number: 389.204
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IMPL-HOLDER F/SYNEX
• Outcome Attributed to Adverse Event: Required Intervention