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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: ARCH LAMINOPLASTY PLATE PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: ARCH LAMINOPLASTY PLATE PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fatigue (1849)
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - plates: arch laminoplasty plate/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. 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. 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 the following journal article: barkley as, et al. (2021), the rare occurrence of reoperation after cervical laminoplasty a 14-year retrospective review of reoperative rates at a single institution, clin spine surg, volume 34, number 6, pages e342¿e348 (usa). The goal of this 14-year single-institution retrospective study was to determine reoperation rates in general, and rates for correction of recurrent or adjacent-level stenosis specifically, after first-time single open-door cervical laminoplasty for cervical spondylotic myelopathy. Between january 2005 and may 2018, a total of 102 patients who underwent first-time laminoplasty for cervical spondylotic myelopathy were included in the study. The mean age of patients was 56. 7 years (±12. 96), and the majority of the patient population were men (74. 5 percent, n
=
76). The majority of cases used the unknown synthes arch laminoplasty system which was implanted to 93 patients with 6-mm spacers in 61 cases and 8-mm spacers in 71 cases. The average follow-up time was 6. 7 months, ranging from 3 months to 10 years. Complications were reported as follows: 2 patients required reoperation for infection and wound dehiscence. Case 1, a (b)(6) year-old woman with proteus syndrome returned 23 months postoperatively with complaints of recurrent upper extremity paresthesia, diminished dexterity, and worsening ataxia. The patient was severely myelopathic and repeat magnetic resonance imaging demonstrated c4¿c5 level stenosis. 6 months later, the patient underwent a revision c3¿c5 laminoplasty with improvement in her symptoms at 1-year follow-up. Case 2, a (b)(6) year-old man presented at 1-year postoperatively with worsening hand intrinsic weakness and an magnetic resonance imaging demonstrated worsened c7¿t1 stenosis. He underwent a c2¿t2 posterior spinal instrumentation and fusion1 month after presenting for these symptoms. At 2-year follow-up, the patient reported improvement in symptoms with some persistent weakness, although improved compared with his preoperative symptoms. This report is for the unknown synthes arch laminoplasty system. This report is for (1) unk - plates: arch laminoplast. This is report 2 of 6 for complaint (b)(4).
 
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Brand NameUNK - PLATES: ARCH LAMINOPLASTY PLATE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12445759
MDR Text Key270506393
Report Number2939274-2021-05239
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/09/2021 Patient Sequence Number: 1
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