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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE; FILLER, BONE VOID, CALCIUM COMPOUND

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SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE; FILLER, BONE VOID, CALCIUM COMPOUND Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown biomaterial - preformed: chronos: spine/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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
Device report from synthes reports an event in (b)(6) as follows: 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: 4 patients had general complications - intraoperative: unknown (4).10 patients had general complications - postoperative surgical before discharge: not documented (6), unknown (4).5 patients had surgical complications - intraoperative adverse events: dural lesion (1), unknown (4).12 patients had surgical complications - postoperative surgical before discharge: other hematoma (2), not documented (6), unknown (4).12 patients had reoperations: at any level due to adjacent segment pathology (8), failure to reach therapeutic goals (1), hardware removal (4), implant failure (1), instability (3), neurocompression (1), non-union (1), other (4), sagittal imbalance (1), unknown (3); and at same level due to hardware removal (1) and other (1).This is for depuy synthes chronos.This is report 2 of 5 for (b)(4).
 
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Brand Name
UNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE
Type of Device
FILLER, BONE VOID, CALCIUM COMPOUND
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 Key11793029
MDR Text Key264707092
Report Number8030965-2021-03714
Device Sequence Number1
Product Code MQV
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 04/30/2021
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? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/30/2021
Initial Date FDA Received05/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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