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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - CEMENT: VERTECEM POLYMETHYLMETHACRYLATE BONE CEMENT

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SYNTHES GMBH UNK - BIOMATERIAL - CEMENT: VERTECEM POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Nerve Damage (1979); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown cement/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Initial reporter is a synthes employee. 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. (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 Description
This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing spinal decompression/fusion. Failed spinal decompression/fusion has been identified as the reported complication as per spine tango registry report experienced by the following with corresponding intervention: 10 patients had general complications - intraoperative: anaesthesiological (2), cardiovascular (1), pulmonary (1), death (1), other (2), not documented (3). 73 patients had general complications - postoperative surgical before discharge: cardiovascular (9), pulmonary (9), cerebral (5), kidney/urinary (9), liver/gi (4), thromboembolism (1), death (3), other (5), not documented (27), and unknown (1). 27 patients had surgical complications - intraoperative adverse events: nerve root damage (1), dural lesion (10), other (16). 52 patients had surgical complications - postoperative surgical before discharge: epidural hematoma (1), other hematoma (1), radiculopathy (2), csf leak/pseudomeningocele (1), motor dysfunction (6), sensory dysfunction (3), wound infection superficial (2), wound infection deep (2), implant failure (1), other (7), not documented (25), and unknown (1). 116 patients had reoperations at any level due to adjacent segment pathology (18), failure to reach therapeutic goals (10), hardware removal (9), implant failure (5), implant malposition (2), instability (18), neurocompression (12), non-union (6), other (20), postoperative infection deep (10), postoperative infection superficial (2), sagittal imbalance (3), and unknown (75). 22 patients had reoperations at the same level due to adjacent segment pathology (5), failure to reach therapeutic goals (4), hardware removal (2), implant failure (1), implant malposition (1), instability (5), neurocompression (8), non-union (1), other (10), postoperative infection deep (5), postoperative infection superficial (2), sagittal imbalance (1), and unknown (5). This is for depuy synthes spine vertecem. This report is for one (1) unknown cement. This is report 3 of 5 for (b)(4).
 
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Brand NameUNK - BIOMATERIAL - CEMENT: VERTECEM
Type of DevicePOLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11214286
MDR Text Key228199066
Report Number8030965-2021-00511
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/22/2021 Patient Sequence Number: 1
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