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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN APEX SELF-DRILLING/SELF-TAPPING PIN (4MM/5MM) IMPLANT

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STRYKER GMBH UNKNOWN APEX SELF-DRILLING/SELF-TAPPING PIN (4MM/5MM) IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Inflammation (1932)
Event Date 01/01/1992
Event Type  Injury  
Manufacturer Narrative
This complaint has been reported during a literature review performed by the post market surveillance group. The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated. Device disposition is unknown.
 
Event Description
The manufacturer became aware of a study from (b)(6) hospital, (b)(6) which was published in july-2003. The title of this report is ¿technique and considerations when using external fixation as a standard treatment of femoral fractures in children¿ which is associated with the stryker unilateral fixator and apex pin system. Within that publication, postoperative complications/ adverse events were reported which occurred between 1992 and 2000. It was not possible to ascertain specific device or patient details from the study, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 46 complaint was initiated retrospectively for adverse event mentioned in the study. This product inquiry addresses grade 2 infections and needed a short period of oral antibiotics. 32 out of 36 cases. The study states, ¿we had 36 out of 96 patients with pin site inflammation/infection. Eighteen patients had a grade 1 infection, which cleared up with local treatment with cleaning. Eighteen patients had grade 2 infections and needed a short period of oral antibiotics. No deep infections were noted. No patient needed parenteral antibiotics and no pins needed to be changed. ¿.
 
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Brand NameUNKNOWN APEX SELF-DRILLING/SELF-TAPPING PIN (4MM/5MM)
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9387435
MDR Text Key185214007
Report Number0008031020-2019-01980
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
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 Received10/31/2019
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/27/2019 Patient Sequence Number: 1
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