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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM SYNTHES USA PRODUCTS LLC UNK - BIOMATERIAL - CEMENT DELIVERY DEVICES: NORIAN: TRAUMA; FILLER, CALCIUM SULFATE PREFORMED PELLETS

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RAYNHAM SYNTHES USA PRODUCTS LLC UNK - BIOMATERIAL - CEMENT DELIVERY DEVICES: NORIAN: TRAUMA; FILLER, CALCIUM SULFATE PREFORMED PELLETS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown biomaterial - cement delivery devices: norian: trauma /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
It was reported that on an unknown date, the patient returned to surgery for removal of vivigen and debridement in distal tibia due to infection and skin breakdown.The patients received the implant on (b)(6) 2020.Procedure and patient outcome are unknown.Concomitant devices reported: bone graft harvesting (part number unknown, lot unknown, quantity 1), nails: tibial (part number unknown, lot unknown, quantity 1).This report involves one (1) unknown biomaterial - cement delivery devices: norian: trauma.This is report 3 of 3 for (b)(4).
 
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Brand Name
UNK - BIOMATERIAL - CEMENT DELIVERY DEVICES: NORIAN: TRAUMA
Type of Device
FILLER, CALCIUM SULFATE PREFORMED PELLETS
Manufacturer (Section D)
RAYNHAM SYNTHES USA PRODUCTS LLC
325 paramount drive
raynham MA 02767
MDR Report Key11011773
MDR Text Key221531154
Report Number1526439-2020-02411
Device Sequence Number1
Product Code MQV
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/18/2020
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 11/18/2020
Initial Date FDA Received12/15/2020
Supplement Dates Manufacturer Received12/15/2020
Supplement Dates FDA Received01/07/2021
Patient Sequence Number1
Treatment
UNK - BONE GRAFT HARVESTING; UNK - NAILS: TIBIAL; UNK - BONE GRAFT HARVESTING; UNK - NAILS: TIBIAL
Patient Outcome(s) Required Intervention;
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