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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, MP, CROSS-PIN, DIAM.2.0X6MM,(5/PACKAGE); IMPLANT
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STRYKER LEIBINGER FREIBURG BONE SCREWS, MP, CROSS-PIN, DIAM.2.0X6MM,(5/PACKAGE); IMPLANT Back to Search Results
Model Number 50-20706
Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Bacterial Infection (1735); Pain (1994)
Event Date 03/01/2020
Event Type  Injury  
Manufacturer Narrative
The device is not available for evaluation as it was discarded by the facility at their location.If additional information is received it will be reported in a supplemental report.The product was discarded by the facility at their location.
 
Event Description
It was reported by a surgeon that a patient required a revision surgery due to experiencing pain and having pus secretions approximately 4-5 weeks after initial implantation with an implant.The original procedure was reported as completed successfully without a delay, but during the revision surgery it was found that the screws had loosened, calcification formed near the plate, and a patient swab tested as (b)(6).The plate was removed.
 
Manufacturer Narrative
The devices were not returned for evaluation, however infection documents (i.E.Laboratory test results) have been received.Thus, the reported event could be confirmed.The patient was treated at the hospital 2 weeks after his mandible was fractured.Patient was admitted on (b)(6) 2020.In the discharge summary, the patient was diagnosed with left angle fracture and an infected right parasymphysis fracture as well as head injury prior to surgery.Patient was also described as diabetic and alcoholic.During the day of the surgery, (b)(6) 2020, a sample was taken of the reported infection.The microbiology report on (b)(6) 2020 shows that the patient is infected with mrsa.The instructions for use (ifu 90-01939, rev.8) advises against the use of the reported devices for patients with active infections.About six weeks post surgery, the patient came back in and tt was discovered that patient had infection and samples were taken.The results show that the patient was infected with the same organism (mrsa).The infection was found at the parasymphysis region and only one of the fixated plates and the screws were infected and has loosened.The plate was ¿(¿) removed and treated.(¿)¿ a review of the postoperative x-ray has shown that plate 55-08216 was used to fixate fractures of the left mandibular angle and right parasymphysis.In the ifu, straight plates are not recommended for mandibular angle fractures.This case was presented to stryker¿s medical expert, as the use of a straight plate to the mandibular angle for fixation may have influenced the loosening.He has stated; ¿the loosening was caused by the infection.¿ in sum, the procedure to fixate mandible fractures when a patient has an active infection is considered as off-label use.Infection is a known adverse event related to this procedure.It has been documented in the instructions for use associated with this device that this type of adverse event may rather be clinically related than implant related.Based on statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.Therefore, no further corrective and / or preventive actions are deemed necessary at this time.Should further information be available, the investigation will be re-evaluated.H3 other text : product was discarded at facility.
 
Event Description
It was reported by a surgeon that a patient required a revision surgery due to experiencing pain and having pus secretions approximately 4-5 weeks after initial implantation with an implant.The original procedure was reported as completed successfully without a delay, but during the revision surgery it was found that the screws had loosened, calcification formed near the plate, and a patient swab tested as mrsa positive.The plate was removed.
 
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Brand Name
BONE SCREWS, MP, CROSS-PIN, DIAM.2.0X6MM,(5/PACKAGE)
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
GM  D-79111
MDR Report Key9877948
MDR Text Key185277416
Report Number0008010177-2020-00017
Device Sequence Number1
Product Code JEY
UDI-Device Identifier34546540602566
UDI-Public34546540602566
Combination Product (y/n)N
PMA/PMN Number
K022185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number50-20706
Device Catalogue Number50-20706
Device Lot Number00000
Was Device Available for Evaluation? No
Date Manufacturer Received03/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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