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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VERTEBRAL BODY SET/SMALL- STERILE; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
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OBERDORF SYNTHES PRODUKTIONS GMBH VERTEBRAL BODY SET/SMALL- STERILE; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY Back to Search Results
Catalog Number 09.804.600S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Injury (2348); Foreign Body In Patient (2687)
Event Date 04/01/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.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.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 after the surgeon had applied the cement he inserted the pestle into the application sleeve to prevent the cement from leaking out.After the cement had hardened the surgeon tried to remove the pestle and the pestle broke off at the third notch (proximal).It remained in the patient.This report is for one (1) vertebral body set/small- sterile.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.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
This is report 1 of 2 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.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.
 
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.Picture review: narrative (broken off part) could be confirmed from the provided x-ray.It looks like a part of the plunger, which is part of the access kit is broken off and remained in the vertebrae.Product was not returned.Based on the provided x-ray the breakage of the plunger could be confirmed.The plunger is part of the access kit ¿ the exact part/lot # of the access kit is not known, hence the review of the device history records could only be done for the vertebral body stent w/balloon.The review revealed that this vertebral body stent w/balloon was manufactured in august 2018 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The event description indicates that after cement application the plunger was inserted into the application sleeve to prevent cement from leaking out.Once the cement had hardened, the surgeon tried to remove the plunger, but the plunger broke off at the third notch and the tip of the plunger remained in the cement/ in the patient.Using the plunger to avoid backflow of the cement into the working sleeve does not comply with the intended use of the plunger and was assessed as an off-label use.For further information / precaution hints please refer to the respective surgical technique (vbs vertebral body stenting system); special attention should be made to the precaution note on page 41: precaution: leave both injection needles inserted while applying the pmma based bone cement to avoid backflow into the working sleeve.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history part: 09.804.600s, lot: 0618055, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 27 aug 2018, expiry date: 01 july 2021.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.
 
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Brand Name
VERTEBRAL BODY SET/SMALL- STERILE
Type of Device
APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9995672
MDR Text Key193953924
Report Number8030965-2020-03084
Device Sequence Number1
Product Code KWQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/01/2021
Device Catalogue Number09.804.600S
Device Lot Number0618055
Was Device Available for Evaluation? No
Date Manufacturer Received06/04/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient Weight113
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