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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN HALF PIN (5 MM) IMPLANT

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STRYKER GMBH UNKNOWN HALF PIN (5 MM) IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/01/2007
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). The title of this report is ¿the use of external fixators in the definitive stabilisation of the pelvis in polytrauma patients: safety, efficacy and clinical outcomes¿ which is associated with the stryker ¿hoffman ii external fixation¿ system. Within that publication, post-operative complications/ adverse events were reported, which occurred from march 2007 to december 2012. It was not possible to ascertain specific device/patient details from the report, 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 38 complaints were initiated retrospectively for adverse events mentioned in the report. This product inquiry addresses malunion. 13 out of 18 cases. The report states: ¿a mal-union of the anterior ring was observed in 18 (30. 5%) cases. There were no posterior ring mal-unions. All mal-unions were classified as fair. None of these patients complained of significant anterior pelvic pain. Anterior ring mal-union was not significantly associated with an unsatisfactory patient outcome. ¿.

 
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Brand NameUNKNOWN HALF PIN (5 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 Key9717855
Report Number0008031020-2020-00434
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 02/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
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 Received01/22/2020
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: 02/17/2020 Patient Sequence Number: 1
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