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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: RECONSTRUCTION PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Nerve Damage (1979)
Event Type  Injury  
Manufacturer Narrative
A total of 23 patients (18 males and 5 females) with a mean age of 35. 3 years (range 17-63) were included in this study. This report is for an unknown 3. 5mm reconstruction plate/unknown lot. Part and lot number 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. (b)(4).
 
Event Description
This report is being filed after the review of the following journal article: routt, m. L. Et. Al. (1996), internal fixation in pelvic fractures and primary repairs of associated genitourinary disruptions: a team approach, the journal of trauma: injury, infection, and critical care, vol. 40(5), pages 784-790 (usa). 10. 1097/00005373-199605000-00018. This study describes a treatment protocol and reports the early results of 23 patients with unstable pelvic fractures and associated bladder or urethral disruptions, or both, treated surgically with open reduction and internal fixation of the anterior pelvic ring injuries at the same anesthetic and using the same surgical exposure as the urethral realignments or bladder repairs, or both. A total of 23 patients (18 males and 5 females) with a mean age of 35. 3 years (range 17-63) were included in this study. 17 patients had anterior pelvic stabilizations, after open reductions, using single 3. 5-mm reconstruction plates (synthes, inc. , paoli, pa. ) of variable lengths dependent upon the injury patterns. 5 patients had 2-hole 4. 5-mm narrow dynamic compression plates (synthes, inc. , paoli, pa) used for symphyseal fixation. Follow-up examinations were available for all the patients and ranged from 3 to 36 months with a mean of 15. 5 months. The following complications were reported as follows: 1 of 3 male patients admitted to impotence. Additional devices for this article are captured on related complaints (b)(4). This report is for an unknown 3. 5mm reconstruction plate. This is report 9 of 10 for (b)(4).
 
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Brand NameUNK - PLATES: RECONSTRUCTION
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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8888545
MDR Text Key154151293
Report Number2939274-2019-59790
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2019
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 Received07/22/2019
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?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/13/2019 Patient Sequence Number: 1
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