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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LDR MÉDICAL DISTR SCREWS Q-STRT 14MM 2PK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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LDR MÉDICAL DISTR SCREWS Q-STRT 14MM 2PK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Device Markings/Labelling Problem (2911)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
This medwatch is submitted to send the initial report.This device is manufactured by tsi (legal manufacturer).However, ldr-(b)(4) add a second label on the box (this second label is non compliant).From information provided, based on the product history records, the supplier investigation and the review of the case the root cause of this event is probably related to operator error during labelling process, if additional informations were received another report will be sent.
 
Event Description
Mobi-c p&f us : mislabeled mobi-c pins.From information provided by sales representative: two boxes of mobi-c were identified with mislabelling issue.The outside top of the box states 12 mm pins and the outside side of the box states 14mm pins.In addition the inside labelling indicate it contains 14mm pins.The pins actual length is 14 mm.This issue was found outside of surgery and no patient was involved.Investigation is in progress.
 
Event Description
It was reported that two boxes of mobi-c pins contained a labeling error.A label on the outside of the boxes stated "12mm" in the description.However, the other labels stated "14mm" and the physical product were "14mm".These were found outside of surgery and had no reported patient impact.
 
Manufacturer Narrative
Correction: a1, b5, b6, b7, e3, h1, h6 (patient code).Additional information: d4 (expiration date and udi), d10, e1 (middle name, address - line 2, state and telephone), g5 (pma/510k), h6 (method codes), h7 and h9.The pins were returned for evaluation.There is a labeling error on the outside of the packaging.It was found that these labels were incorrectly printed at the ldr austin facility.A field action was conducted via 3004788213-03272019-001r and reported to the fda.
 
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Brand Name
DISTR SCREWS Q-STRT 14MM 2PK
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
LDR MÉDICAL
quartier europe de l¿ouest
5, rue de berlin
sainte-savine 10300
FR  10300
MDR Report Key8463269
MDR Text Key140331116
Report Number3004788213-2019-00103
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/01/2022
Device Model NumberN/A
Device Catalogue Number0024-LDR
Device Lot Number2017102450
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/05/2018
Initial Date FDA Received03/29/2019
Supplement Dates Manufacturer Received03/25/2020
Supplement Dates FDA Received04/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number3004788213-03272019-001R
Patient Sequence Number1
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