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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN APEX PIN IMPLANT

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STRYKER GMBH UNKNOWN APEX PIN IMPLANT Back to Search Results
Catalog Number UNK_SEL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); No Code Available (3191)
Event Date 11/01/2012
Event Type  Injury  
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided. This complaint has been reported during a literature review performed by the post market surveillance group. No product identification is possible. 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 reviewed ifu, however, states that the deep venous thrombosis is one of the most frequent adverse effects involving the use of internal fracture fixation devices and adverse results may be clinically related rather than device related. Also, the surgeon must warn patients of surgical risks, and make them aware of possible adverse effects. The patient should be warned that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity or trauma. Based on the available information, no relation could be established between the device and the reported event. A review of the labeling did not indicate any abnormalities. Ifu also states: "contraindications: the physician¿s education, training and professional judgment must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of failure includes: any active or suspected latent infection or marked local inflammation in or about the affected area. Adverse effects: in many instances, adverse results may be clinically related rather than device related. The following are the most frequent adverse effects involving the use of internal fracture fixation devices: conditions attributable to non-union, osteoporosis, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone. Increased fibrous tissue response around the fracture site due to unstable comminuted fractures. [¿] deep venous thrombosis. Avascular necrosis. [¿] subclinical nerve damage may possibly occur as a result of the surgical trauma. " if any further information is provided, the investigation report will be updated. Device evaluated by mfr: device disposition unknown.
 
Event Description
The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6) medical campus ((b)(6)). The title of this report is ¿a post-market clinical follow-up (pmcf) of the treatment of fractures with the apex pins in conjunction with stryker external fixation systems¿ which was published in april 2019 and is associated with the stryker apex pin. Within that publication, post-operative complications/ adverse events were reported, which occurred between november 2012 to september 2018. It was not possible to ascertain specific device or patient information 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, 52 complaints were initiated retrospectively for different adverse events mentioned in the journal. This product inquiry addresses osteomyelitis and secondary operation. 2 out of 4 cases.
 
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Brand NameUNKNOWN APEX PIN
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
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8709471
MDR Text Key148409033
Report Number0008031020-2019-00655
Device Sequence Number1
Product Code HSB
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 06/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2019
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 Received05/22/2019
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: 06/18/2019 Patient Sequence Number: 1
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