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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.112.082
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems No Consequences Or Impact To Patient (2199); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Reporter telephone number is reported as (b)(6). 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
Device report from synthes reports an event in (b)(6) as follows: it was reported revision surgery occurred on (b)(6) 2020, due to device failure and non-union of the bone. The plate and six (6) 3. 5 mm stainless steel cortex screws were removed during the revision. It is unknown what the patient was revised to. The original implantation of an lcp superior clavicle plate was implanted in the patient on an unknown date in 2018. It was determined the cortical screws backed out of the lcp plate by x-ray on an unknown date. It was reported that the screws were thought to have been implanted and tightened correctly in the original surgery. This is report 1 of 7 for (b)(4).
 
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Brand Name3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10580343
MDR Text Key208345853
Report Number2939274-2020-04296
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K111540
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number02.112.082
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 Received09/22/2020
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: 09/24/2020 Patient Sequence Number: 1
Treatment
UNK - SCREWS: CORTEX
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