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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KLS MARTIN LP LEVEL ONE CMF; PLATE, FIXATION, BONE
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KLS MARTIN LP LEVEL ONE CMF; PLATE, FIXATION, BONE Back to Search Results
Model Number 25-878-06-09
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/15/2018
Event Type  malfunction  
Event Description
While the surgeon was putting the (b)(4) screw in the skull to hold the (b)(4) star, the first screw broke.Then he got a new screw to put in and did the surgery.When we was taking the second screw out after the surgery it also broke.The patient has 2 broken (b)(4) screws retained in the skull.The screws were distributed by (b)(4), ref# (b)(4).According to (b)(4), the screws are manufactured by kls martin, ref# 25-878-06-09.Manufacturer response for screw, (brand not provided) (per site reporter).The screw were distributed by (b)(4).The (b)(4) rep told us the screws are manufactured by kls martin.They also said this has not been a common problem in the recent past.
 
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Brand Name
LEVEL ONE CMF
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
KLS MARTIN LP
11201 saint john¿s industrial pkwy s
jacksonville FL 32246
MDR Report Key8168774
MDR Text Key130494550
Report Number8168774
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number25-878-06-09
Device Catalogue Number25-878-06-09
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/06/2018
Event Location Hospital
Date Report to Manufacturer12/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age12410 DA
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