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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; POLYMETHYLMETHACRYLATE BONE CEMENT
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OBERDORF SYNTHES PRODUKTIONS GMBH; POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Device Problem No Apparent Adverse Event (3189)
Patient Problem Nerve Damage (1979)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown biomaterial - cement: spine /unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent a spinal fusion procedure, an adjustment on level 2 due to hypermobility and nerve root compression.The patient had previous operations on levels 3, 4 & 5 with uss polyaxial cement augmentation spondylodese on an unknown date.So all the screws were explanted and completed the surgery by switching into a pedicle screw system.There was a 120 minutes surgical delay.It was unknown if there were fragments generated from the broken devices.It was unknown if there were adverse event to the patient reported.This report is for one (1) biomaterial - cement: spine.This is report 6 of 6 for (b)(4).This complaint and complaints (b)(4) capture the post-operative event that involved the fifty-five (56) polyaxial screws explanted due to hypermobility and nerve root compression and switched to a pedicle screw system, while, (b)(4) captures the intra-operative events that involved the broken screws during tightening of the nut.
 
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.The initial complaint was reviewed and found not reportable.(no cement was used on this surgery, this is now non-reportable.) investigation summary this complaint was entered to capture the revision surgery due to hypermobility and nerve root compression.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventive 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
On 7/31/2019: this report for: the initial complaint was reviewed and found not reportable, therefore, (b)(4) for (b)(6) is being rescinded due to no cement was used for the surgery.
 
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Type of Device
POLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8732162
MDR Text Key149122849
Report Number8030965-2019-65705
Device Sequence Number1
Product Code NDN
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
Report Date 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received07/31/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
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