MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFIX® EVOLUTION TRIAL SPACER HOLDER; TEMPLATE

Catalog Number	03.835.100
Medical Device Problem Code	Device Difficult to Maintain (3134)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: synthes sales rep.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 conclusion could be drawn at the time of filing 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during an anterior lumbar interbody fusion (alif) procedure for two levels, the surgeon had been using the synfix evolution trial implant and completed the level one.During the procedure, the trial implant had been tapped into place and then removed and a larger trial was then tapped into place.However, when the surgeon tried to remove an inserter or synfix evolution implant holder, it would not unscrew the trial.Also, there were no other tools in which to try to set apart from the inserter.The instrument was meant to be tapped into place, however, it seemed to be unsuccessful.It was unknown if there was surgical delay.Surgical procedure and patient outcome were unknown.Concomitant device reported: unknown trial (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) devices.This report is for 1 of 1 for (b)(4).
Event or Problem Description
The last trial size got stuck but he¿d decided this was the biggest he could use so moved on to implant insertion.No harm to the patient.Alif was successful on both levels l4 and l5.The upper levels l3,l2, l1 had xlif cages inserted during a separate operation, however they did subside but these were competitor's cages.Concomitant devices reported: unknown trial implants (part# unknown, lot# unknown, quantity 2).
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
H10 additional narrative: b5: updated information provided for reporting.E1: additional reporter.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
07/11/2019: update: it was reported that the reason why the patient underwent the procedure was to reinstate lordosis into the lumbar spine.The procedure was successfully completed with no surgical delay reported.Updated concomitant device/s reported to capture the number of trial implants (3) used.Concomitant device/s reported: unknown trial implants (part# unknown, lot# unknown, quantity 3).

• Brand Name: SYNFIX® EVOLUTION TRIAL SPACER HOLDER
• Common Device Name: TEMPLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8772814
• Report Number: 8030965-2019-66098
• Device Sequence Number: 1668820
• Product Code: HWT
• UDI-Device Identifier: 07611819682719
• UDI-Public: (01)07611819682719
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.835.100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/08/2019; 08/29/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 08/08/2019; 09/04/2019
• Patient Sequence Number: 1