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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH CP LAG SCREW ANCHORAGE 2 CP Ø3.6MM, L30MM (T8); PLATE, FIXATION, BONE
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STRYKER GMBH CP LAG SCREW ANCHORAGE 2 CP Ø3.6MM, L30MM (T8); PLATE, FIXATION, BONE Back to Search Results
Catalog Number 626930
Device Problems Break (1069); Degraded (1153)
Patient Problems Failure of Implant (1924); Injury (2348); Non-union Bone Fracture (2369); No Known Impact Or Consequence To Patient (2692)
Event Date 09/18/2019
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device disposition is unknown.
 
Event Description
It was reported that the patient's left foot was revised due to a broken screw.Possible cause reported as patient weight bearing too early.Intra operatively, little pieces of metal were found in the patient.The plate was inspected and had no visible damage.The threading of the screws was visibly degraded.Patient was revised to competitor devices.Rep reported that no further information will be released by the hospital or surgeon.
 
Event Description
It was reported that the patient's left foot was revised due to a broken screw.Possible cause reported as patient weight bearing too early.Intra operatively, little pieces of metal were found in the patient.The plate was inspected and had no visible damage.The threading of the screws was visibly degraded.Patient was revised to competitor devices.Rep reported that no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
The reported event could not be confirmed.Device evaluation: the reported device was returned and inspected with the following results listed below: visual inspection: reveals no significant damage to standard screw thread line.Superficial scratch marks observed on several parts of screw.As reported in the initial event details, ¿the threading of the screws was visibly degraded.¿.This could not be confirmed based on results of returned device inspection.This device is concomitant and did not contribute to the reported failure.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be updated.
 
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Brand Name
CP LAG SCREW ANCHORAGE 2 CP Ø3.6MM, L30MM (T8)
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key9179752
MDR Text Key173179466
Report Number0008031020-2019-01414
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K151769
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number626930
Device Lot NumberL55629
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2019
Date Manufacturer Received01/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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