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

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).

• 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 Key: 11793029
• MDR Text Key: 264707092
• Report Number: 8030965-2021-03714
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Date FDA Received: 05/07/2021
• 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 Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention