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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN FIXOS COMPRESSION SCREW (Ø 4.0 MM/Ø 5.0 MM/Ø 7.0 MM) IMPLANT

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STRYKER GMBH UNKNOWN FIXOS COMPRESSION SCREW (Ø 4.0 MM/Ø 5.0 MM/Ø 7.0 MM) IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Impaired Healing (2378)
Event Date 10/01/2015
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 post market clinical follow-up (pmcf) from (b)(6). The title of this report is ¿a retrospective data collection of the fixation, correction, and stabilization of small and long bones in adult and adolescent patients with the use of cannulated, headless, compression screws¿ which was published in july-2019 and is associated with the stryker fixos screw system. Within that publication, post-operative complications/ adverse events were reported, which occurred between october-2015 to april-2019. It was not possible to ascertain specific device catalog from the article, 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 7 complaints were initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses nonunion. 4 out of 6 cases. The report states,¿there were 7 adverse events reported out of 32 cases, however, none were device-related. The most common adverse event was nonunion, which was seen in 6 (19%) of cases. [¿]although 19% of cases resulted in complications of nonunion, this cannot be attributed to the fixation alone. ¿.
 
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Brand NameUNKNOWN FIXOS COMPRESSION SCREW (Ø 4.0 MM/Ø 5.0 MM/Ø 7.0 MM)
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 Key8902109
MDR Text Key155850930
Report Number0008031020-2019-01063
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 08/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2019
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 Received07/23/2019
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: 08/16/2019 Patient Sequence Number: 1
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