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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: SYNAPSE ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: SYNAPSE ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION Back to Search Results
Catalog Number UNK - CONSTRUCTS: SYNAPSE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Failure of Implant (1924); Inflammation (1932); Nerve Damage (1979); Stenosis (2263); Impaired Healing (2378); Spinal Cord Injury (2432); Post Operative Wound Infection (2446); Inadequate Osseointegration (2646); Neuralgia (4413); Vertebral Fracture (4520); Intervertebral Disc Compression or Protrusion (4524); Solid Tumour (4552)
Event Type  Injury  
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Brand NameUNK - CONSTRUCTS: SYNAPSE
Type of DeviceORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 
MDR Report Key12134909
Report Number2939274-2021-03488
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,STUDY
Reporter Occupation
Type of Report Initial
Report Date 06/14/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK - CONSTRUCTS: SYNAPSE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2021
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? Yes
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 07/08/2021 Patient Sequence Number: 1
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